55 results on '"Klarenbeek BR"'
Search Results
2. Alterations in myofilament function contribute to left ventricular dysfunction in pigs early after myocardial infarction
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Velden, J, Merkus, Daphne, Klarenbeek, BR, James, AT, Boontje, NM, Dekkers, Dick, Stienen, GJM, Lamers, Jos, Duncker, Dirk-jan, Cardiology, and Biochemistry
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- 2004
3. Percutaneous gallbladder drainage for xanthogranulomatous cholecystitis.
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Klarenbeek BR, van Veen SAJ, and Stockmann HBA
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- 2008
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4. Oncologists' communication about tobacco and alcohol use during treatment for esophagogastric cancer: a qualitative observational study of simulated consultations.
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Hoek DWBD, van de Water LF, Vos PG, Hoedjes M, Roodbeen R, Klarenbeek BR, Geijsen D, Smets EMA, van Laarhoven HWM, and Henselmans I
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- Humans, Male, Female, Middle Aged, Netherlands, Physician-Patient Relations, Palliative Care methods, Smoking Cessation methods, Smoking Cessation psychology, Aged, Adult, Patient Simulation, Practice Patterns, Physicians' statistics & numerical data, Esophageal Neoplasms therapy, Alcohol Drinking epidemiology, Oncologists, Stomach Neoplasms therapy, Communication, Qualitative Research
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Purpose: Tobacco and alcohol use influence cancer risk as well as treatment outcomes, specifically for esophageal and gastric cancer patients. Therefore, it is an important topic to discuss during consultations. This study aims to uncover medical, radiation, and surgical oncologists' communication about substance use, i.e., tobacco and alcohol use, in simulated consultations about curative and palliative esophagogastric cancer treatment., Methods: Secondary analyses were performed on n = 40 standardized patient assessments (SPAs) collected in three Dutch clinical studies. Simulated patients with esophagogastric cancer were instructed to ask about smoking or alcohol use during treatment. The responses of the 40 medical, radiation, and surgical oncologists were transcribed verbatim, and thematic analysis was performed in MAXQDA., Results: Oncologists consistently advocated smoking cessation during curative treatment. There was more variation in their recommendations and arguments in the palliative compared to the curative setting and when addressing alcohol use instead of smoking. Overall, oncologists were less stringent regarding behavior change in the palliative than in the curative setting. Few oncologists actively inquired about the patient's perspective on the substance use behavior, the recommended substance use change, or the support offered., Conclusion: Clear guidelines for oncologists on when and how to provide unequivocal recommendations about substance use behavior change and support to patients are needed. Oncologists might benefit from education on how to engage in a conversation about smoking or alcohol., (© 2024. The Author(s).)
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- 2024
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5. Long-Term Functional Outcome After Early vs. Late Stoma Closure in Rectal Cancer Surgery: Sub-analysis of the Multicenter FORCE Trial.
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Meyer VM, Bosch N, van der Heijden JAG, Kalkdijk-Dijkstra AJ, Pierie JPEN, Beets GL, Broens PMA, Klarenbeek BR, and van Westreenen HL
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- Humans, Male, Female, Aged, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications etiology, Treatment Outcome, Time Factors, Proctectomy adverse effects, Proctectomy methods, Rectal Neoplasms surgery, Quality of Life, Surgical Stomas adverse effects, Fecal Incontinence etiology
- Abstract
Purpose: The aim of this study was to assess the effect of early stoma closure on bowel function after low anterior resection (LAR) for rectal cancer., Methods: Patients participating in the FORCE trial who underwent LAR with protective stoma were included in this study. Patients were subdivided into an early closure group (< 3 months) and late closure group (> 3 months). Endpoints of this study were the Wexner Incontinence, low anterior resection syndrome (LARS), EORTC QLQ-CR29, and fecal incontinence quality of life (FIQL) scores at 1 year., Results: Between 2017 and 2020, 38 patients had received a diverting stoma after LAR for rectal cancer and could be included. There was no significant difference in LARS (31 vs. 30, p = 0.63) and Wexner score (6.2 vs. 5.8, p = 0.77) between the early and late closure groups. Time to stoma closure in days was not a predictor for LARS (R
2 = 0.001, F (1,36) = 0.049, p = 0.83) or Wexner score (R2 = 0.008, F (1,36) = 0.287, p = 0.60) after restored continuity. There was no significant difference between any of the FIQL domains of lifestyle, coping, depression, and embarrassment. In the EORTC QLQ-29, body image scored higher in the late closure group (21.3 vs. 1.6, p = 0.004)., Conclusion: Timing of stoma closure does not appear to affect long-term bowel function and quality of life, except for body image. To improve functional outcome, attention should be focused on other contributing factors., (© 2024. The Author(s).)- Published
- 2024
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6. Extent and Boundaries of Lymph Node Stations During Minimally Invasive Esophagectomy: A Survey Among Dutch Esophageal Surgeons.
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Ketel MHM, van der Aa DC, Henckens SPG, Rosman C, van Berge Henegouwen MI, Klarenbeek BR, and Gisbertz SS
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- Humans, Netherlands, Cross-Sectional Studies, Surveys and Questionnaires, Minimally Invasive Surgical Procedures, Practice Patterns, Physicians' statistics & numerical data, Adenocarcinoma surgery, Adenocarcinoma pathology, Prognosis, Follow-Up Studies, Female, Esophagectomy methods, Esophageal Neoplasms surgery, Esophageal Neoplasms pathology, Lymph Node Excision methods, Surgeons, Lymph Nodes pathology, Lymph Nodes surgery
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Background: The optimal extent of lymph node dissection (LND) and the anatomic boundaries per lymph node station (LNS) during minimally invasive esophagectomy (MIE) for esophageal cancer remain a topic of debate. This study investigated the opinion of Dutch esophageal cancer surgeons on their routine LND extent and anatomic boundaries per LNS during MIE., Methods: In April 2023, an English web-based cross-sectional survey was conducted. In each of the 15 Dutch hospitals performing MIE, two MIE surgeons were asked to participate. The routine LND extent (quantity, specific LNS) for distal esophageal adenocarcinoma, (dis)agreement with the TIGER definition, and anatomic boundaries for each LNS in six directions were queried., Results: The survey was completed by 24 Dutch MIE surgeons (80% response rate). Consensus on the routine LND extent ( ≥ 85% of the participating surgeons) included the left and right paracardial, left gastric artery, celiac trunk, proximal splenic artery, common hepatic artery, subcarinal middle mediastinal paraoesophageal, lower mediastinal paraoesophageal, pulmonary ligament, and upper mediastinal paraoesophageal LNSs. Other LNSs were not widely considered routine. Although, certain anatomic boundaries were consistent among the surgeons, the majority varied, even when they agreed on the TIGER definition., Conclusion: Significant variations in surgical practice among Dutch esophageal surgeons regarding their routine extent of LND and anatomic boundaries of LNSs during MIE were demonstrated. Variation may have an impact on clinical outcomes, hampering uniform treatment strategies and hindering comparison of performance assessments. This study highlighted the need for an international follow-up study toward one uniform defined LND during MIE for esophageal cancer., (© 2024. The Author(s).)
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- 2024
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7. Minimally Invasive transCervical oEsophagectomy (MICE) for oesophageal cancer: prospective cohort study (IDEAL stage 2A).
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Vercoulen RJMT, van Veenendaal L, Kramer IF, Hutteman M, Shiozaki A, Fujiwara H, Rosman C, and Klarenbeek BR
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- Humans, Prospective Studies, Female, Male, Middle Aged, Aged, Feasibility Studies, Neoplasm Staging, Esophagectomy methods, Esophagectomy adverse effects, Esophageal Neoplasms surgery, Postoperative Complications etiology, Postoperative Complications epidemiology, Minimally Invasive Surgical Procedures methods
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Background: Minimally invasive transcervical oesophagectomy is a surgical technique that offers radical oesophagectomy without the need for transthoracic access. The aim of this study was to evaluate the safety and feasibility of the minimally invasive transcervical oesophagectomy procedure and to report the refinement of this technique in a Western cohort., Methods: A single-centre prospective cohort study was designed as an IDEAL stage 2A study. Patients with oesophageal cancer (cT1b-4a N0-3 M0) who were scheduled for oesophagectomy with curative intent were eligible for inclusion in the study. The main outcome parameter was the postoperative pulmonary complication rate and the secondary outcomes were the anastomotic leakage, recurrent laryngeal nerve palsy, and R0 resection rates, as well as the lymph node yield., Results: In total, 75 patients underwent minimally invasive transcervical oesophagectomy between January 2021 and November 2023. Several modifications to the surgical technique were registered, evaluated, and implemented in the context of IDEAL stage 2A. A total of 12 patients (16%) had postoperative pulmonary complications, including pneumonia (4 patients) and pleural effusion with drainage or aspiration (8 patients). Recurrent laryngeal nerve palsy was observed in 33 of 75 patients (44%), with recovery in 30 of 33 patients (91%). A total of 5 of 75 patients (7%) had anastomotic leakage. The median number of resected lymph nodes was 29 (interquartile range 22-37) and the R0 resection rate was 96% (72 patients)., Conclusion: Introducing minimally invasive transcervical oesophagectomy for oesophageal cancer in a Dutch institution is associated with a low rate of postoperative pulmonary complications and a high rate of temporary recurrent laryngeal nerve palsy., (© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.)
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- 2024
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8. Pelvic Floor Rehabilitation After Rectal Cancer Surgery One-year follow-up of a Multicenter Randomized Clinical Trial (FORCE trial).
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Bosch NM, Kalkdijk-Dijkstra AJ, van Westreenen HL, Broens P, Pierie J, van der Heijden J, and Klarenbeek BR
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Objective: This study aims to evaluate the effects of pelvic floor rehabilitation (PFR) after low anterior resection (LAR) at one-year follow-up., Summary Background Data: After LAR, with restoration of bowel continuity, up to 90% of patients develop anorectal dysfunction, significantly impacting their quality of life. However, standardized treatment is currently unavailable. The FORCE trial demonstrated the beneficial effects of PFR after three months regarding specific domains of the Fecal Incontinence QoL (FIQL) questionnaire and urgency compared to usual care., Methods: The FORCE trial is a multicenter, two-arm, randomized clinical trial. All patients undergoing LAR were randomly assigned to receive either usual care or a standardized PFR program. The primary outcome measure is the Wexner incontinence score, and the secondary endpoints included the LARS score, the EORTC colorectal-specific QoL questionnaire, and health- and fecal incontinence-related QoL. Assessments were conducted at baseline before randomization, at three months and one-year follow-ups., Results: A total of 86 patients were included (PFR: n=40, control: n=46). After one year, PFR did not significantly improve Wexner incontinence scores (PFR: -3.33, 95% CI -4.41 to -2.26, control: -2.54, 95% CI -3.54 to -1.54, P=0.30). Similar to the three-month follow-up, patients without near-complete incontinence at baseline showed sustained improvement in fecal incontinence (PFR: -2.82, 95% CI -3.86 to -1.76, control: -1.43, 95% CI -2.36 to -0.50, P=0.06). Significant improvement was reported in the FIQL domains Lifestyle (PFR: 0.51, control: -0.13, P=0.03) and Coping and Behavior (PFR: 0.40, control: -0.24, P=0.01)., Conclusion: At one-year follow-up, no significant differences were found in fecal incontinence scores; however, PFR was associated with improved fecal incontinence related QoL compared to usual care., Competing Interests: Conflict of interest statement: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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9. Implementation of Pelvic Floor Rehabilitation after rectal cancer surgery: A qualitative study guided by the Consolidated Framework for Implementation Research (CFIR).
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Bosch NM, Kalkdijk-Dijkstra AJ, Broens PMA, van Westreenen HL, Pierie JPEN, Klarenbeek BR, and van der Heijden JAG
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- Humans, Female, Male, Middle Aged, Aged, Focus Groups, Adult, Rectal Neoplasms surgery, Qualitative Research, Pelvic Floor surgery
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Background: Pelvic Floor Rehabilitation (PFR) is effective in a selection of patients with low anterior resection syndrome (LARS) after rectal cancer surgery. This study aimed to identify barriers and enablers to prepare for successful implementation into clinical practice., Methods: A qualitative study was performed, guided by the Consolidated Framework for Implementation Research (CFIR). Individual interviews (n = 27) and two focus groups were conducted to synthesize the perspectives of rectal cancer patients, pelvic floor (PF) physiotherapists, and medical experts., Results: Barriers were found to be the absence of guidelines about LARS treatment, underdeveloped network care, suboptimal patient information, and expectation management upfront to PFR. Financial status is frequently a barrier because insurance companies do not always reimburse PFR. Enablers were the current level of evidence for PFR, the positive relationship between patients and PF physiotherapists, and the level of self-motivation by patients., Conclusion: The factors identified in our study play a crucial role in ensuring a successful implementation of PFR after rectal cancer surgery., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Bosch et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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10. Nationwide Association of Surgical Performance of Minimally Invasive Esophagectomy With Patient Outcomes.
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Ketel MHM, Klarenbeek BR, Abma I, Belgers EHJ, Coene PLO, Dekker JWT, van Duijvendijk P, Emous M, Gisbertz SS, Haveman JW, Heisterkamp J, Nieuwenhuijzen GAP, Ruurda JP, van Sandick JW, van der Sluis PC, van Det MJ, van Esser S, Law S, de Steur WO, Sosef MN, Wijnhoven B, Hannink G, Rosman C, and van Workum F
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- Male, Humans, Aged, Cohort Studies, Treatment Outcome, Minimally Invasive Surgical Procedures, Postoperative Complications etiology, Esophagectomy adverse effects, Esophageal Neoplasms surgery, Esophageal Neoplasms complications
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Importance: Suboptimal surgical performance is hypothesized to be associated with less favorable patient outcomes in minimally invasive esophagectomy (MIE). Establishing this association may lead to programs that promote better surgical performance of MIE and improve patient outcomes., Objective: To investigate associations between surgical performance and postoperative outcomes after MIE., Design, Setting, and Participants: In this nationwide cohort study of 15 Dutch hospitals that perform more than 20 MIEs per year, 7 masked expert MIE surgeons assessed surgical performance using videos and a previously developed and validated competency assessment tool (CAT). Each hospital submitted 2 representative videos of MIEs performed between November 4, 2021, and September 13, 2022. Patients registered in the Dutch Upper Gastrointestinal Cancer Audit between January 1, 2020, and December 31, 2021, were included to examine patient outcomes., Exposure: Hospitals were divided into quartiles based on their MIE-CAT performance score. Outcomes were compared between highest (top 25%) and lowest (bottom 25%) performing quartiles. Transthoracic MIE with gastric tube reconstruction., Main Outcome and Measure: The primary outcome was severe postoperative complications (Clavien-Dindo ≥3) within 30 days after surgery. Multilevel logistic regression, with clustering of patients within hospitals, was used to analyze associations between performance and outcomes., Results: In total, 30 videos and 970 patients (mean [SD] age, 66.6 [9.1] years; 719 men [74.1%]) were included. The mean (SD) MIE-CAT score was 113.6 (5.5) in the highest performance quartile vs 94.1 (5.9) in the lowest. Severe postoperative complications occurred in 18.7% (41 of 219) of patients in the highest performance quartile vs 39.2% (40 of 102) in the lowest (risk ratio [RR], 0.50; 95% CI, 0.24-0.99). The highest vs the lowest performance quartile showed lower rates of conversions (1.8% vs 8.9%; RR, 0.21; 95% CI, 0.21-0.21), intraoperative complications (2.7% vs 7.8%; RR, 0.21; 95% CI, 0.04-0.94), and overall postoperative complications (46.1% vs 65.7%; RR, 0.54; 95% CI, 0.24-0.96). The R0 resection rate (96.8% vs 94.2%; RR, 1.03; 95% CI, 0.97-1.05) and lymph node yield (mean [SD], 38.9 [14.7] vs 26.2 [9.0]; RR, 3.20; 95% CI, 0.27-3.21) increased with oncologic-specific performance (eg, hiatus dissection, lymph node dissection). In addition, a high anastomotic phase score was associated with a lower anastomotic leakage rate (4.6% vs 17.7%; RR, 0.14; 95% CI, 0.06-0.31)., Conclusions and Relevance: These findings suggest that better surgical performance is associated with fewer perioperative complications for patients with esophageal cancer on a national level. If surgical performance of MIE can be improved with MIE-CAT implementation, substantially better patient outcomes may be achievable.
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- 2024
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11. A Video-Based Procedure-Specific Competency Assessment Tool for Minimally Invasive Esophagectomy.
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Ketel MHM, Klarenbeek BR, Eddahchouri Y, Cheong E, Cuesta MA, van Daele E, Ferri LE, Gisbertz SS, Gutschow CA, Hubka M, Hölscher AH, Law S, Luyer MDP, Merritt RE, Morse CR, Mueller CL, Nieuwenhuijzen GAP, Nilsson M, Pattyn P, Shen Y, van den Wildenberg FJH, Abma IL, Rosman C, and van Workum F
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- Humans, Reproducibility of Results, Lymph Node Excision adverse effects, Postoperative Complications etiology, Esophagectomy adverse effects, Esophageal Neoplasms surgery
- Abstract
Importance: Minimally invasive esophagectomy (MIE) is a complex procedure with substantial learning curves. In other complex minimally invasive procedures, suboptimal surgical performance has convincingly been associated with less favorable patient outcomes as assessed by peer review of the surgical procedure., Objective: To develop and validate a procedure-specific competency assessment tool (CAT) for MIE., Design, Setting, and Participants: In this international quality improvement study, a procedure-specific MIE-CAT was developed and validated. The MIE-CAT contains 8 procedural phases, and 4 quality components per phase are scored with a Likert scale ranging from 1 to 4. For evaluation of the MIE-CAT, intraoperative MIE videos performed by a single surgical team in the Esophageal Center East Netherlands were peer reviewed by 18 independent international MIE experts (with more than 120 MIEs performed). Each video was assessed by 2 or 3 blinded experts to evaluate feasibility, content validity, reliability, and construct validity. MIE-CAT version 2 was composed with refined content aimed at improving interrater reliability. A total of 32 full-length MIE videos from patients who underwent MIE between 2011 and 2020 were analyzed. Data were analyzed from January 2021 to January 2023., Exposure: Performance assessment of transthoracic MIE with an intrathoracic anastomosis., Main Outcomes and Measures: Feasibility, content validity, interrater and intrarater reliability, and construct validity, including correlations with both experience of the surgical team and clinical parameters, of the developed MIE-CAT., Results: Experts found the MIE-CAT easy to understand and easy to use to grade surgical performance. The MIE-CAT demonstrated good intrarater reliability (range of intraclass correlation coefficients [ICCs], 0.807 [95% CI, 0.656 to 0.892] for quality component score to 0.898 [95% CI, 0.846 to 0.932] for phase score). Interrater reliability was moderate (range of ICCs, 0.536 [95% CI, -0.220 to 0.994] for total MIE-CAT score to 0.705 [95% CI, 0.473 to 0.846] for quality component score), and most discrepancies originated in the lymphadenectomy phases. Hypothesis testing for construct validity showed more than 75% of hypotheses correct: MIE-CAT performance scores correlated with experience of the surgical team (r = 0.288 to 0.622), blood loss (r = -0.034 to -0.545), operative time (r = -0.309 to -0.611), intraoperative complications (r = -0.052 to -0.319), and severe postoperative complications (r = -0.207 to -0.395). MIE-CAT version 2 increased usability. Interrater reliability improved but remained moderate (range of ICCs, 0.666 to 0.743), and most discrepancies between raters remained in the lymphadenectomy phases., Conclusions and Relevance: The MIE-CAT was developed and its feasibility, content validity, reliability, and construct validity were demonstrated. By providing insight into surgical performance of MIE, the MIE-CAT might be used for clinical, training, and research purposes.
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- 2024
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12. Assessing real-world representativeness of prospective registry cohorts in oncology: insights from patients with esophagogastric cancer.
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Kuijper SC, Besseling J, Klausch T, Slingerland M, van der Zijden CJ, Kouwenhoven EA, Beerepoot LV, Mohammad NH, Klarenbeek BR, Verhoeven RHA, and van Laarhoven HWM
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- Humans, Netherlands epidemiology, Registries, Stomach Neoplasms epidemiology, Stomach Neoplasms therapy, Esophageal Neoplasms epidemiology, Esophageal Neoplasms therapy
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Objectives: This study aimed to explore the real-world representativeness of a prospective registry cohort with active accrual in oncology, applying a representativeness metric that is novel to health care., Study Design and Setting: We used data from the Prospective Observational Cohort Study of Esophageal-Gastric Cancer Patients (POCOP) registry and from the population-based Netherlands Cancer Registry (NCR). We used Representativeness-indicators (R-indicators) and overall survival to investigate the degree to which the POCOP cohort and clinically relevant subgroups were a representative sample compared to the NCR database. Calibration using inverse propensity score weighting was applied to correct differences between POCOP and NCR., Results: The R-indicator of the entire POCOP registry was 0.72 95% confidence interval [0.71, 0.73]. Representativeness of palliative patients was higher than that of potentially curable patients (R-indicator 0.88 [0.85, 0.90] and 0.70 [0.68, 0.71], respectively). Stratification to clinically relevant subgroups based on treatment resulted in higher R-indicators of the respective subgroups. Both after stratification and calibration weighting survival estimates in the POCOP registry were more similar to that in the NCR population., Conclusion: This study demonstrated the assessment of real-world representativeness of patients who participated in a prospective registry cohort and showed that real-world representativeness improved when the variability in treatment was accounted for., Competing Interests: Declaration of competing interest MS has served as a consultant for BMS and Lilly. NHM has served as a consultant for BMS, Merck, Lilly, Astra Zeneca and Servier. RV reports grants from BMS and has served as a consultant for Daiichi Sankyo. HvL has served as a consultant for BMS, Dragonfly, Lilly, Merck, Nordic Pharma and Servier and has received research funding and/or medication supply from Bayer, BMS, Celgene, Janssen, Incyte, Lilly, Merck, Nordic Pharma, Nordic, Philips, Roche and Servier. SCK, JB, TK, CJvdZ, EAK, LvB, and BRK have no disclosures., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2023
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13. Surviving the nonsurvivable combination of a mycotic aneurysm progressing into a concomitant aorto-bronchial- and aorto-esophageal fistula, a case report.
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Somers T, Klarenbeek BR, Kouijzer IJE, Verhagen AFTM, and Verkroost MWA
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- Humans, Aneurysm, Infected diagnostic imaging, Aneurysm, Infected surgery, Aortic Diseases surgery, Esophageal Fistula diagnosis, Esophageal Fistula surgery
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Background: Aortic mycotic aneurysms are a rare but life-threatening condition and may be associated with aorto-bronchial- and aorto-esophageal fistulas. Although both very rare, they carry a high mortality and require (urgent) surgical intervention. Surviving all three conditions concomitantly is extraordinary. We describe a patient who underwent staged repair of such combined defects., (© 2023. BioMed Central Ltd., part of Springer Nature.)
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- 2023
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14. Crowd-sourced and expert video assessment in minimally invasive esophagectomy.
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Ketel MHM, Klarenbeek BR, Eddahchouri Y, Cuesta MA, van Daele E, Gutschow CA, Hölscher AH, Hubka M, Luyer MDP, Merritt RE, Nieuwenhuijzen GAP, Shen Y, Abma IL, Rosman C, and van Workum F
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- Humans, Reproducibility of Results, Esophagectomy, Clinical Competence, Crowdsourcing, Laparoscopy, Esophageal Neoplasms
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Background: Video-based assessment by experts may structurally measure surgical performance using procedure-specific competency assessment tools (CATs). A CAT for minimally invasive esophagectomy (MIE-CAT) was developed and validated previously. However, surgeon's time is scarce and video assessment is time-consuming and labor intensive. This study investigated non-procedure-specific assessment of MIE video clips by MIE experts and crowdsourcing, collective surgical performance evaluation by anonymous and untrained laypeople, to assist procedure-specific expert review., Methods: Two surgical performance scoring frameworks were used to assess eight MIE videos. First, global performance was assessed with the non-procedure-specific Global Operative Assessment of Laparoscopic Skills (GOALS) of 64 procedural phase-based video clips < 10 min. Each clip was assessed by two MIE experts and > 30 crowd workers. Second, the same experts assessed procedure-specific performance with the MIE-CAT of the corresponding full-length video. Reliability and convergent validity of GOALS for MIE were investigated using hypothesis testing with correlations (experience, blood loss, operative time, and MIE-CAT)., Results: Less than 75% of hypothesized correlations between GOALS scores and experience of the surgical team (r < 0.3), blood loss (r = - 0.82 to 0.02), operative time (r = - 0.42 to 0.07), and the MIE-CAT scores (r = - 0.04 to 0.76) were met for both crowd workers and experts. Interestingly, experts' GOALS and MIE-CAT scores correlated strongly (r = 0.40 to 0.79), while crowd workers' GOALS and experts' MIE-CAT scores correlations were weak (r = - 0.04 to 0.49). Expert and crowd worker GOALS scores correlated poorly (ICC ≤ 0.42)., Conclusion: GOALS assessments by crowd workers lacked convergent validity and showed poor reliability. It is likely that MIE is technically too difficult to assess for laypeople. Convergent validity of GOALS assessments by experts could also not be established. GOALS might not be comprehensive enough to assess detailed MIE performance. However, expert's GOALS and MIE-CAT scores strongly correlated indicating video clip (instead of full-length video) assessments could be useful to shorten assessment time., (© 2023. The Author(s).)
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- 2023
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15. Introduction of Minimally Invasive transCervical oEsophagectomy (MICE) according to the IDEAL framework.
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Klarenbeek BR, Fujiwara H, Scholte M, Rovers M, Shiozaki A, and Rosman C
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- Humans, Postoperative Complications etiology, Postoperative Complications prevention & control, Postoperative Complications surgery, Minimally Invasive Surgical Procedures, Esophagectomy, Esophageal Neoplasms surgery
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- 2023
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16. The effectiveness of neoadjuvant chemoradiotherapy in oesophageal adenocarcinoma with presence of extracellular mucin, signet-ring cells, and/or poorly cohesive cells.
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Valkema MJ, Vos AM, van der Post RS, Ooms AH, Oudijk L, Eyck BM, Lagarde SM, Wijnhoven BP, Klarenbeek BR, Rosman C, van Lanschot JJB, and Doukas M
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- Humans, Mucins, Retrospective Studies, Neoadjuvant Therapy, Adenocarcinoma, Esophageal Neoplasms
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Oesophageal adenocarcinomas may show different histopathological patterns, including excessive acellular mucin pools, signet-ring cells (SRCs), and poorly cohesive cells (PCCs). These components have been suggested to correlate with poor outcomes after neoadjuvant chemoradiotherapy (nCRT), which might influence patient management. However, these factors have not been studied independently of each other with adjustment for tumour differentiation grade (i.e. the presence of well-formed glands), which is a possible confounder. We studied the pre- and post-treatment presence of extracellular mucin, SRCs, and/or PCCs in relation to pathological response and prognosis after nCRT in patients with oesophageal or oesophagogastric junction adenocarcinoma. A total of 325 patients were retrospectively identified from institutional databases of two university hospitals. All patients were scheduled for ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) nCRT and oesophagectomy between 2001 and 2019. Percentages of well-formed glands, extracellular mucin, SRCs, and PCCs were scored in pre-treatment biopsies and post-treatment resection specimens. The association between histopathological factors (≥1 and >10%) and tumour regression grade 3-4 (i.e. >10% residual tumour), overall survival, and disease-free survival (DFS) was evaluated, adjusted for tumour differentiation grade amongst other clinicopathological variables. In pre-treatment biopsies, ≥1% extracellular mucin was present in 66 of 325 patients (20%); ≥1% SRCs in 43 of 325 (13%), and ≥1% PCCs in 126 of 325 (39%). We show that pre-treatment histopathological factors were unrelated to tumour regression grade. Pre-treatment presence of >10% PCCs was associated with lower DFS (hazard ratio [HR] 1.73, 95% CI 1.19-2.53). Patients with post-treatment presence of ≥1% SRCs had higher risk of death (HR 1.81, 95% CI 1.10-2.99). In conclusion, pre-treatment presence of extracellular mucin, SRCs, and/or PCCs is unrelated to pathological response. The presence of these factors should not be an argument to refrain from CROSS. At least 10% PCCs pre-treatment and any SRCs post-treatment, irrespective of the tumour differentiation grade, seem indicative of inferior prognosis, but require further validation in larger cohorts., (© 2023 The Authors. The Journal of Pathology: Clinical Research published by The Pathological Society of Great Britain and Ireland and John Wiley & Sons Ltd.)
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- 2023
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17. Circulating tumor DNA detection after neoadjuvant treatment and surgery predicts recurrence in patients with early-stage and locally advanced rectal cancer.
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Hofste LSM, Geerlings MJ, von Rhein D, Rütten H, Westenberg AH, Weiss MM, Gilissen C, Hofste T, van der Post RS, Klarenbeek BR, de Wilt JHW, and Ligtenberg MJL
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- Humans, Neoadjuvant Therapy, Rectum pathology, Chemoradiotherapy, Circulating Tumor DNA genetics, Rectal Neoplasms genetics, Rectal Neoplasms therapy
- Abstract
Introduction: Patients with early-stage and locally advanced rectal cancer are often treated with neoadjuvant therapy followed by surgery or watch and wait. This study evaluated the role of circulating tumor DNA (ctDNA) to measure disease after neoadjuvant treatment and surgery to optimize treatment choices., Materials and Methods: Patients with rectal cancer treated with both chemotherapy and radiotherapy were included and diagnostic biopsies were analyzed for tumor-specific mutations. Presence of ctDNA was measured in plasma by tracing the tumor-informed mutations using a next-generation sequencing panel. The association between ctDNA detection and clinicopathological characteristics and progression-free survival was measured., Results: Before treatment ctDNA was detected in 69% (35/51) of patients. After neoadjuvant therapy ctDNA was detected in only 15% (5/34) of patients. In none of the patients with a complete clinical response who were selected for a watch and wait strategy (0/10) or patients with ypN0 disease (0/8) ctDNA was detected, whereas it was detected in 31% (5/16) of patients with ypN + disease. After surgery ctDNA was detected in 16% (3/19) of patients, of which all (3/3) developed recurrent disease compared to only 13% (2/16) in patients with undetected ctDNA after surgery. In an exploratory survival analysis, both ctDNA detection after neoadjuvant therapy and after surgery was associated with worse progression-free survival (p = 0.01 and p = 0.007, respectively, Cox-regression)., Conclusion: These data show that in patients with early-stage and locally advanced rectal cancer tumor-informed ctDNA detection in plasma using ultradeep sequencing may have clinical value to complement response prediction after neoadjuvant therapy and surgery., Competing Interests: Declaration of competing interest Prof. Marjolijn Ligtenberg received consulting fees from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Illumina, Janssen Pharmaceuticals, Lilly, Merck Sharp & Dohme and Roche. All these relations were not related to this study and were paid to the institution. Prof. Johannes de Wilt received research funding from Dutch Cancer Society, ZonMw and Metronic. These relations were not related to this study and were paid to the institution. All other authors declare that they have no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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18. Treatment of anastomotic leak after oesophagectomy for oesophageal cancer: large, collaborative, observational TENTACLE cohort study.
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Ubels S, Verstegen MHP, Klarenbeek BR, Bouwense S, van Berge Henegouwen MI, Daams F, van Det MJ, Griffiths EA, Haveman JW, Heisterkamp J, Nieuwenhuijzen G, Polat F, Schouten J, Siersema PD, Singh P, Wijnhoven B, Hannink G, van Workum F, and Rosman C
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- Humans, Anastomosis, Surgical adverse effects, Cohort Studies, Esophagectomy adverse effects, Ischemia surgery, Necrosis complications, Necrosis surgery, Retrospective Studies, Anastomotic Leak etiology, Anastomotic Leak surgery, Esophageal Neoplasms surgery, Esophageal Neoplasms complications
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Background: Anastomotic leak is a severe complication after oesophagectomy. Anastomotic leak has diverse clinical manifestations and the optimal treatment strategy is unknown. The aim of this study was to assess the efficacy of treatment strategies for different manifestations of anastomotic leak after oesophagectomy., Methods: A retrospective cohort study was performed in 71 centres worldwide and included patients with anastomotic leak after oesophagectomy (2011-2019). Different primary treatment strategies were compared for three different anastomotic leak manifestations: interventional versus supportive-only treatment for local manifestations (that is no intrathoracic collections; well perfused conduit); drainage and defect closure versus drainage only for intrathoracic manifestations; and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis. The primary outcome was 90-day mortality. Propensity score matching was performed to adjust for confounders., Results: Of 1508 patients with anastomotic leak, 28.2 per cent (425 patients) had local manifestations, 36.3 per cent (548 patients) had intrathoracic manifestations, 9.6 per cent (145 patients) had conduit ischaemia/necrosis, 17.5 per cent (264 patients) were allocated after multiple imputation, and 8.4 per cent (126 patients) were excluded. After propensity score matching, no statistically significant differences in 90-day mortality were found regarding interventional versus supportive-only treatment for local manifestations (risk difference 3.2 per cent, 95 per cent c.i. -1.8 to 8.2 per cent), drainage and defect closure versus drainage only for intrathoracic manifestations (risk difference 5.8 per cent, 95 per cent c.i. -1.2 to 12.8 per cent), and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis (risk difference 0.1 per cent, 95 per cent c.i. -21.4 to 1.6 per cent). In general, less morbidity was found after less extensive primary treatment strategies., Conclusion: Less extensive primary treatment of anastomotic leak was associated with less morbidity. A less extensive primary treatment approach may potentially be considered for anastomotic leak. Future studies are needed to confirm current findings and guide optimal treatment of anastomotic leak after oesophagectomy., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)
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- 2023
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19. Clinical Validity of Tumor-Informed Circulating Tumor DNA Analysis in Patients Undergoing Surgery of Colorectal Metastases.
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Hofste LSM, Geerlings MJ, Kamping EJ, Kouwenhoven NDH, von Rhein D, Jansen EAM, Garms LM, Nagtegaal ID, van der Post RS, de Wilt JHW, Klarenbeek BR, and Ligtenberg MJL
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- Humans, Retrospective Studies, Colorectal Neoplasms surgery, Circulating Tumor DNA, Cell-Free Nucleic Acids, Rectal Neoplasms, Colonic Neoplasms
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Background: Accurate biomarkers to monitor tumor load and response in metastatic colorectal cancer patients undergoing surgery could optimize treatment regimens., Objective: This study aimed to explore the clinical validity of tumor-informed quantification of circulating tumor DNA in blood using ultradeep sequencing., Design: Resection specimens from 53 colorectal cancer patients were analyzed for tumor-specific mutations in 15 genes. These mutations were used to measure the presence of circulating tumor DNA in preoperatively collected plasma samples using hybrid capture-based sequencing. Additional postoperative measurements were performed 1 week after surgery in 16 patients., Settings: The study was conducted at the Radboud University Medical Center., Patients: A total of 53 colorectal cancer patients undergoing surgery of metastases were included., Main Outcome Measures: The detection of circulating tumor DNA., Results: At least 1 tumor-specific mutation was detected in all tumor samples. In preoperative plasma samples, circulating tumor DNA was detected in 88% (37/42) of systemic treatment-naïve patients and in 55% (6/11) of patients who received preoperative chemotherapy. More specifically, circulating tumor DNA was detected in 0% (0/3) of cases with a subtotal or partial pathologic response and in 75% (6/8) of cases without a pathologic response in the resection specimen ( p = 0.06). In postoperative plasma samples, circulating tumor DNA was detected in 80% (4/5) of patients with an incomplete resection and in 0% (0/11) of those with a complete resection ( p = 0.003)., Limitations: The study was limited by the heterogeneity of the cohort and the small number of postoperative plasma samples., Conclusions: These data indicate that tumor-informed circulating tumor DNA detection in the plasma of patients undergoing surgery for metastatic colorectal cancer is feasible and may have clinical value in response monitoring and predicting residual disease. Prospective studies are needed to establish the clinical utility of circulating tumor DNA analysis to guide treatment decisions in these patients. See Video Abstract at http://links.lww.com/DCR/B990 ., Validez Clnica Del Anlisis De Adn Del Tumor Circulante Informado Por El Tumor En Pacientes Sometidos a Ciruga De Metstasis Colorrectales: ANTECEDENTES:Los biomarcadores precisos para monitorear la carga tumoral y la respuesta en pacientes con cáncer colorrectal metastásico que se someten a cirugía podrían optimizar los regímenes de tratamiento.OBJETIVO:Este estudio explora la validez clínica de la cuantificación informada por el tumor del ADN tumoral circulante en sangre mediante secuenciación ultraprofunda.DISEÑO:Se analizaron muestras de resección de 53 pacientes con cáncer colorrectal en busca de mutaciones específicas del tumor en quince genes. Estas mutaciones se usaron para medir la presencia de ADN tumoral circulante en muestras de plasma recolectadas antes de la operación usando secuenciación basada en captura híbrida. Se realizaron mediciones postoperatorias adicionales una semana después de la cirugía en dieciséis pacientes.AJUSTES:El estudio se realizó en el centro médico de la universidad de Radboud.PACIENTES:Se incluyeron un total de 53 pacientes con cáncer colorrectal sometidos a cirugía de metástasis.PRINCIPALES MEDIDAS DE RESULTADO:La detección de ADN tumoral circulante.RESULTADOS:Se detectó al menos una mutación específica de tumor en todas las muestras de tumor. En muestras de plasma preoperatorias, se detectó ADN tumoral circulante en el 88% (37/42) de los pacientes sin tratamiento sistémico previo y en el 55% (6/11) de los pacientes que recibieron quimioterapia preoperatoria. Más concretamente, en el 0% (0/3) de los casos con respuesta patológica subtotal o parcial y en el 75% (6/8) de los casos sin respuesta patológica en la pieza de resección ( p = 0,06). En muestras de plasma postoperatorio se detectó ADN tumoral circulante en el 80% (4/5) de los pacientes con una resección incompleta y en el 0% (0/11) de los que tenían resección completa ( p = 0,003).LIMITACIONES:El estudio estuvo limitado por la heterogeneidad de la cohorte y el pequeño número de muestras de plasma postoperatorias.CONCLUSIONES:Estos datos indican que la detección de ADN tumoral circulante informado por el tumor en el plasma de pacientes sometidos a cirugía por cáncer colorrectal metastásico es factible y puede tener valor clínico en el control de la respuesta y la predicción de la enfermedad residual. Se necesitan estudios prospectivos para establecer la utilidad clínica del análisis de ADN tumoral circulante para guiar las decisiones de tratamiento en estos pacientes. Consulte Video Resumen en http://links.lww.com/DCR/B990 . (Traducción-Dr. Mauricio Santamaria )., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Colon and Rectal Surgeons.)
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- 2023
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20. Treatment of anastomotic leak after esophagectomy: insights of an international case vignette survey and expert discussions.
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Ubels S, Lubbers M, Verstegen MHP, Bouwense SAW, van Daele E, Ferri L, Gisbertz SS, Griffiths EA, Grimminger P, Hanna G, Hubka M, Law S, Low D, Luyer M, Merritt RE, Morse C, Mueller CL, Nieuwenhuijzen GAP, Nilsson M, Reynolds JV, Ribeiro U, Rosati R, Shen Y, Wijnhoven BPL, Klarenbeek BR, van Workum F, and Rosman C
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- Humans, Anastomotic Leak etiology, Anastomotic Leak surgery, Retrospective Studies, Anastomosis, Surgical adverse effects, Anastomosis, Surgical methods, Surveys and Questionnaires, Esophagectomy methods, Esophageal Neoplasms
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Anastomotic leak (AL) is a severe complication after esophagectomy. Clinical presentation of AL is diverse and there is large practice variation regarding treatment of AL. This study aimed to explore different AL treatment strategies and their underlying rationale. This mixed-methods study consisted of an international survey among upper gastro-intestinal (GI) surgeons and focus groups with expert upper GI surgeons. The survey included 10 case vignettes and data sources were integrated after separate analysis. The survey was completed by 188 respondents (completion rate 69%) and 6 focus groups were conducted with 20 international experts. Prevention of mortality was the most important goal of primary treatment. Goals of secondary treatment were to promote tissue healing, return to oral feeding and safe hospital discharge. There was substantial variation in the preferred treatment principles (e.g. drainage or defect closure) and modalities (e.g. stent or endoVAC) within different presentations of AL. Patients with local symptoms were treated by supportive means only or by non-surgical drainage and/or defect closure. Drainage was routinely performed in patients with intrathoracic collections and often combined with defect closure. Patients with conduit necrosis were predominantly treated by resection and reconstruction of the anastomosis or by esophageal diversion. This mixed-methods study shows that overall treatment strategies for AL are determined by vitality of the conduit and presence of intrathoracic collections. There is large variation in preferred treatment principles and modalities. Future research may investigate optimal treatment for specific AL presentations and aim to develop consensus-based treatment guidelines for AL after esophagectomy., (© The Author(s) 2022. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus.)
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- 2022
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21. Circulating Tumor DNA-Based Disease Monitoring of Patients with Locally Advanced Esophageal Cancer.
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Hofste LSM, Geerlings MJ, von Rhein D, Tolmeijer SH, Weiss MM, Gilissen C, Hofste T, Garms LM, Janssen MJR, Rütten H, Rosman C, van der Post RS, Klarenbeek BR, and Ligtenberg MJL
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Patients diagnosed with locally advanced esophageal cancer are often treated with neoadjuvant chemoradiotherapy followed by surgery. This study explored whether detection of circulating tumor DNA (ctDNA) in plasma can be used to predict residual disease during treatment. Diagnostic tissue biopsies from patients with esophageal cancer receiving neoadjuvant chemoradiotherapy and surgery were analyzed for tumor-specific mutations. These tumor-informed mutations were used to measure the presence of ctDNA in serially collected plasma samples using hybrid capture-based sequencing. Plasma samples were obtained before chemoradiotherapy, and prior to surgery. The association between ctDNA detection and progression-free and overall survival was measured. Before chemoradiotherapy, ctDNA was detected in 56% (44/78) of patients and detection was associated with tumor stage and volume ( p = 0.05, Fisher exact and p = 0.02, Mann-Whitney, respectively). After chemoradiotherapy, ctDNA was detected in 10% (8/78) of patients. This preoperative detection of ctDNA was independently associated with recurrent disease (hazard ratio 2.8, 95% confidence interval 1.1-6.8, p = 0.03, multivariable Cox-regression) and worse overall survival (hazard ratio 2.9, 95% confidence interval 1.2-7.1, p = 0.02, multivariable Cox-regression).Ultradeep sequencing-based detection of ctDNA in preoperative plasma of patients with locally advanced esophageal cancer may help to assess which patients have a high risk of recurrence after neoadjuvant chemoradiotherapy and surgery.
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- 2022
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22. Pelvic Floor Rehabilitation After Rectal Cancer Surgery: A Multicenter Randomized Clinical Trial (FORCE Trial).
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van der Heijden JAG, Kalkdijk-Dijkstra AJ, Pierie JPEN, van Westreenen HL, Broens PMA, and Klarenbeek BR
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- Humans, Netherlands, Pelvic Floor surgery, Quality of Life, Treatment Outcome, Fecal Incontinence, Rectal Neoplasms surgery
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Objective: To investigate the effects of PFR after LAR compared to usual care without PFR., Summary of Background Data: Functional complaints, including fecal incontinence, often occur after LAR for rectal cancer. Controversy exists about the effectiveness of PFR in improving such postoperative functional outcomes., Methods: This was a multicenter, randomized controlled trial involving 17 Dutch centers. Patients after LAR for rectal cancer were randomly assigned (1:1) to usual care or PFR and stratified by sex and administration of neoadjuvant therapy. Selection was not based on severity of complaints at baseline. Baseline measurements were taken 3 months after surgery without temporary stoma construction or 6 weeks after stoma closure. The primary outcome measure was the change in Wexner incontinence scores 3 months after randomization. Secondary outcomes were fecal incontinence-related quality of life, colorectal-specific quality of life, and the LARS scores., Results: Between October 2017 and March 2020, 128 patients were enrolled and 106 randomly assigned (PFR n = 51, control n = 55); 95 patients (PFR n = 44, control n = 51) were assessable for final analysis. PFR did not lead to larger changes in Wexner incontinence scores in nonselected patients after LAR compared to usual care [PFR: -2.3, 95% confidence interval (CI) -3.3 to -1.4, control: -1.3, 95% CI -2.2 to -0.4, P = 0.13]. However, PFR was associated with less urgency at follow-up (odds ratio 0.22, 95% CI 0.06-0.86). Patients without near-complete incontinence reported larger Wexner score improvements after PFR (PFR: -2.1, 95% CI -3.1 to -1.1, control: -0.7, 95% CI -1.6 to 0.2, P = 0.045). For patients with at least moderate incontinence PFR resulted in relevant improvements in all fecal incontinence-related quality of life domains, while the control group deteriorated. These improvements were even larger when patients with near-complete incontinence were excluded. No serious adverse PFR-related events occurred., Conclusion: No benefit was found of PFR in all patients but several subgroups were identified that did benefit from PFR, such as patients with urgency or with at least moderate incontinence and no near-complete incontinence. A selective referral policy (65%-85% of all patients) is suggested to improve postoperative functional outcomes for patients after LAR for rectal cancer., Trial Registration: Netherlands Trial Registration, NTR5469, registered on 3 September 2015., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2022
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23. Learning Curves of Ivor Lewis Totally Minimally Invasive Esophagectomy by Hospital and Surgeon Characteristics: A Retrospective Multinational Cohort Study.
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Claassen L, Hannink G, Luyer MDP, Ainsworth AP, van Berge Henegouwen MI, Cheong E, Daams F, van Det MJ, van Duijvendijk P, Gisbertz SS, Gutschow CA, Heisterkamp J, Kauppi JT, Klarenbeek BR, Kouwenhoven EA, Langenhoff BS, Larsen MH, Martijnse IS, Nieuwenhoven EJV, van der Peet DL, Pierie JEN, Pierik REGJM, Polat F, Räsänen JV, Rouvelas I, Sosef MN, Wassenaar EB, Wildenberg FJHVD, van der Zaag ES, Nilsson M, Nieuwenhuijzen GAP, van Workum F, and Rosman C
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- Cohort Studies, Esophagectomy methods, Hospitals, Humans, Learning Curve, Minimally Invasive Surgical Procedures methods, Postoperative Complications epidemiology, Retrospective Studies, Treatment Outcome, Esophageal Neoplasms complications, Esophageal Neoplasms surgery, Laparoscopy methods, Surgeons
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Objective: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors., Background: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning., Methods: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision., Results: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision., Conclusions: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2022
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24. Author response to: Transanal total mesorectal excision and low anterior resection syndrome.
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van der Heijden JAG, Qaderi SM, Verhoeven R, Custers JAE, Klarenbeek BR, Maaskant-Braat AJG, and de Wilt JHW
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- Humans, Postoperative Complications etiology, Postoperative Complications surgery, Rectum surgery, Syndrome, Laparoscopy, Proctectomy, Rectal Neoplasms surgery, Transanal Endoscopic Surgery
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- 2022
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25. Validation of In Vivo Nodal Assessment of Solid Malignancies with USPIO-Enhanced MRI: A Workflow Protocol.
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Driessen DAJJ, de Gouw DJJM, Stijns RCH, Litjens G, Israël B, Philips BWJ, Hermans JJ, Dijkema T, Klarenbeek BR, van der Post RS, Nagtegaal ID, van Engen-van Grunsven ACH, Brosens LAA, Veltien A, Zámecnik P, and Scheenen TWJ
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Background: In various cancer types, the first step towards extended metastatic disease is the presence of lymph node metastases. Imaging methods with sufficient diagnostic accuracy are required to personalize treatment. Lymph node metastases can be detected with ultrasmall superparamagnetic iron oxide (USPIO)-enhanced magnetic resonance imaging (MRI), but this method needs validation. Here, a workflow is presented, which is designed to compare MRI-visible lymph nodes on a node-to-node basis with histopathology., Methods: In patients with prostate, rectal, periampullary, esophageal, and head-and-neck cancer, in vivo USPIO-enhanced MRI was performed to detect lymph nodes suspicious of harboring metastases. After lymphadenectomy, but before histopathological assessment, a 7 Tesla preclinical ex vivo MRI of the surgical specimen was performed, and in vivo MR images were radiologically matched to ex vivo MR images. Lymph nodes were annotated on the ex vivo MRI for an MR-guided pathological examination of the specimens., Results: Matching lymph nodes of ex vivo MRI to pathology was feasible in all cancer types. The annotated ex vivo MR images enabled a comparison between USPIO-enhanced in vivo MRI and histopathology, which allowed for analyses on a nodal, or at least on a nodal station, basis., Conclusions: A workflow was developed to validate in vivo USPIO-enhanced MRI with histopathology. Guiding the pathologist towards lymph nodes in the resection specimens during histopathological work-up allowed for the analysis at a nodal basis, or at least nodal station basis, of in vivo suspicious lymph nodes with corresponding histopathology, providing direct information for validation of in vivo USPIO-enhanced, MRI-detected lymph nodes.
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- 2022
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26. European consensus on essential steps of Minimally Invasive Ivor Lewis and McKeown Esophagectomy through Delphi methodology.
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Eddahchouri Y, van Workum F, van den Wildenberg FJH, van Berge Henegouwen MI, Polat F, van Goor H, Pierie JEN, Klarenbeek BR, Gisbertz SS, and Rosman C
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- Consensus, Humans, Learning Curve, Minimally Invasive Surgical Procedures methods, Postoperative Complications surgery, Retrospective Studies, Esophageal Neoplasms surgery, Esophagectomy methods
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Background: Minimally invasive esophagectomy (MIE) is a complex and technically demanding procedure with a long learning curve, which is associated with increased morbidity and mortality. To master MIE, training in essential steps is crucial. Yet, no consensus on essential steps of MIE is available. The aim of this study was to achieve expert consensus on essential steps in Ivor Lewis and McKeown MIE through Delphi methodology., Methods: Based on expert opinion and peer-reviewed literature, essential steps were defined for Ivor Lewis (IL) and McKeown (McK) MIE. In a round table discussion, experts finalized the lists of steps and an online Delphi questionnaire was sent to an international expert panel (7 European countries) of minimally invasive upper GI surgeons. Based on replies and comments, steps were adjusted and rephrased and sent in iterative fashion until consensus was achieved., Results: Two Delphi rounds were conducted and response rates were 74% (23 out of 31 experts) for the first and 81% (27 out of 33 experts) for the second round. Consensus was achieved on 106 essential steps for both the IL and McK approach. Cronbach's alpha in the first round was 0.78 (IL) and 0.78 (McK) and in the second round 0.92 (IL) and 0.88 (McK)., Conclusions: Consensus among European experts was achieved on essential surgical steps for both Ivor Lewis and McKeown minimally invasive esophagectomy., (© 2021. The Author(s).)
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- 2022
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27. Outcomes of Patients with Anastomotic Leakage After Transhiatal, McKeown or Ivor Lewis Esophagectomy: A Nationwide Cohort Study.
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Verstegen MHP, Slaman AE, Klarenbeek BR, van Berge Henegouwen MI, Gisbertz SS, Rosman C, and van Workum F
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- Anastomotic Leak epidemiology, Anastomotic Leak etiology, Cohort Studies, Humans, Postoperative Complications epidemiology, Retrospective Studies, Esophageal Neoplasms surgery, Esophagectomy adverse effects
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Background: Anastomotic leakage has a great impact on clinical outcomes after esophagectomy. It has never been studied whether anastomotic leakage is of equal severity between different types of esophagectomy (i.e., transhiatal, McKeown and Ivor Lewis) in terms of postoperative mortality and morbidity., Methods: All esophageal cancer patients with anastomotic leakage after transhiatal, McKeown or Ivor Lewis esophagectomy between 2011 and 2019 were selected from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) registry. The primary outcome was 30-day/in-hospital mortality. Secondary outcomes included postoperative complications, re-operation and ICU readmission rate., Results: Data from 1030 patients with anastomotic leakage after transhiatal (n=287), McKeown (n=397) and Ivor Lewis esophagectomy (n=346) were evaluated. The 30-day/in-hospital mortality rate was 4.5% in patients with leakage after transhiatal esophagectomy, 8.1% after McKeown and 8.1% after Ivor Lewis esophagectomy (P=0.139). After correction for confounders, leakage after transhiatal resection was associated with lower mortality (OR 0.152-0.699, P=0.004), but mortality after McKeown and Ivor Lewis esophagectomy was similar. Re-operation rate was 24.0% after transhiatal, 40.6% after McKeown and 41.3% after Ivor Lewis esophagectomy (P<0.001). ICU readmission rate was 24.0% after transhiatal, 37.8% after McKeown and 43.4% after Ivor Lewis esophagectomy (P<0.001)., Conclusion: This study in patients with anastomotic leakage confirms a strong association between severity of clinical consequences and different types of esophagectomy. It supports the hypothesis that cervical leakage is generally less severe than intrathoracic leakage. The clinical impact of anastomotic leakage should be taken into account, in addition to its incidence, when different types of esophagectomy are compared by clinicians or researchers., (© 2021. The Author(s).)
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- 2021
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28. Transanal total mesorectal excision and low anterior resection syndrome.
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van der Heijden JAG, Qaderi SM, Verhoeven R, Custers JAE, Klarenbeek BR, Maaskant-Braat AJG, and de Wilt JHW
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- Female, Humans, Incidence, Laparoscopy methods, Male, Middle Aged, Netherlands epidemiology, Proctectomy methods, Prospective Studies, Syndrome, Transanal Endoscopic Surgery methods, Laparoscopy adverse effects, Postoperative Complications epidemiology, Proctectomy adverse effects, Propensity Score, Rectal Neoplasms surgery, Rectum surgery, Transanal Endoscopic Surgery adverse effects
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Background: Bowel dysfunction after rectal cancer surgery is common, with some experiencing low anterior resection syndrome (LARS) is common after rectal cancer surgery. This study examined if transanal total mesorectal excision (TaTME) has a similar risk of LARS and altered quality of life (QoL) as patients who undergo low anterior resection (LAR)., Methods: Patients who underwent TaTME or traditionally approached total mesorectal excision in a prospective colorectal cancer cohort study (2014-2019) were propensity score matched in a 1 : 1 ratio. LARS and QoL scores were assessed before and after surgery with a primary endpoint of major LARS at 12 months analysed for possible association between factors by logistic regression., Results: Of 61 TaTME and 317 LAR patients eligible, 55 from each group were propensity score matched. Higher LARS scores (30.6 versus 25.4, P = 0.010) and more major LARS (65 versus 42 per cent, P = 0.013; OR 2.64, 95 per cent c.i. 1.22 to 5.71) were reported after TaTME. Additionally, QoL score differences (body image, bowel frequency, and embarrassment) were worse in the TaTME group., Conclusions: TaTME may be associated with more severe bowel dysfunction than traditional approaches to rectal cancer., (© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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29. Intrathoracic vs Cervical Anastomosis After Totally or Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial.
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van Workum F, Verstegen MHP, Klarenbeek BR, Bouwense SAW, van Berge Henegouwen MI, Daams F, Gisbertz SS, Hannink G, Haveman JW, Heisterkamp J, Jansen W, Kouwenhoven EA, van Lanschot JJB, Nieuwenhuijzen GAP, van der Peet DL, Polat F, Ubels S, Wijnhoven BPL, Rovers MM, and Rosman C
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- Aged, Anastomosis, Surgical, Carcinoma mortality, Carcinoma pathology, Esophageal Neoplasms mortality, Esophageal Neoplasms pathology, Esophagectomy methods, Esophagogastric Junction, Female, Humans, Length of Stay, Male, Middle Aged, Minimally Invasive Surgical Procedures, Netherlands, Quality of Life, Treatment Outcome, Anastomotic Leak epidemiology, Carcinoma surgery, Esophageal Neoplasms surgery, Esophagectomy adverse effects
- Abstract
Background: Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE., Objective: To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial., Design, Setting, and Participants: This open, multicenter randomized clinical superiority trial was performed at 9 Dutch high-volume hospitals. Patients with midesophageal to distal esophageal or gastroesophageal junction cancer planned for curative resection were included. Data collection occurred from April 2016 through February 2020., Intervention: Patients were randomly assigned (1:1) to transthoracic MIE with intrathoracic or cervical anastomosis., Main Outcomes and Measures: The primary end point was anastomotic leakage requiring endoscopic, radiologic, or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality, and quality of life., Results: Two hundred sixty-two patients were randomized, and 245 were eligible for analysis. Anastomotic leakage necessitating reintervention occurred in 15 of 122 patients with intrathoracic anastomosis (12.3%) and in 39 of 123 patients with cervical anastomosis (31.7%; risk difference, -19.4% [95% CI, -29.5% to -9.3%]). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference, -21.9% [95% CI, -32.1% to -11.6%]). Intensive care unit length of stay, mortality rates, and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with fewer severe complications (risk difference, -11.3% [-20.4% to -2.2%]), lower incidence of recurrent laryngeal nerve palsy (risk difference, -7.3% [95% CI, -12.1% to -2.5%]), and better quality of life in 3 subdomains (mean differences: dysphagia, -12.2 [95% CI, -19.6 to -4.7]; problems of choking when swallowing, -10.3 [95% CI, -16.4 to 4.2]; trouble with talking, -15.3 [95% CI, -22.9 to -7.7])., Conclusions and Relevance: In this randomized clinical trial, intrathoracic anastomosis resulted in better outcome for patients treated with transthoracic MIE for midesophageal to distal esophageal or gastroesophageal junction cancer., Trial Registration: Trialregister.nl Identifier: NL4183 (NTR4333).
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- 2021
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30. SOURCE: Prediction Models for Overall Survival in Patients With Metastatic and Potentially Curable Esophageal and Gastric Cancer.
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van den Boorn HG, Abu-Hanna A, Haj Mohammad N, Hulshof MCCM, Gisbertz SS, Klarenbeek BR, Slingerland M, Beerepoot LV, Rozema T, Sprangers MAG, Verhoeven RHA, van Oijen MGH, Zwinderman KH, and van Laarhoven HWM
- Subjects
- Decision Making, Shared, Humans, Models, Theoretical, Neoplasm Metastasis, Netherlands, Prospective Studies, Registries, Research Design, Survival Analysis, Esophageal Neoplasms diagnosis, Esophageal Neoplasms therapy, Stomach Neoplasms diagnosis, Stomach Neoplasms therapy
- Abstract
Background: Personalized prediction of treatment outcomes can aid patients with cancer when deciding on treatment options. Existing prediction models for esophageal and gastric cancer, however, have mostly been developed for survival prediction after surgery (ie, when treatment has already been completed). Furthermore, prediction models for patients with metastatic cancer are scarce. The aim of this study was to develop prediction models of overall survival at diagnosis for patients with potentially curable and metastatic esophageal and gastric cancer (the SOURCE study)., Methods: Data from 13,080 patients with esophageal or gastric cancer diagnosed in 2015 through 2018 were retrieved from the prospective Netherlands Cancer Registry. Four Cox proportional hazards regression models were created for patients with potentially curable and metastatic esophageal or gastric cancer. Predictors, including treatment type, were selected using the Akaike information criterion. The models were validated with temporal cross-validation on their C-index and calibration., Results: The validated model's C-index was 0.78 for potentially curable gastric cancer and 0.80 for potentially curable esophageal cancer. For the metastatic models, the c-indices were 0.72 and 0.73 for esophageal and gastric cancer, respectively. The 95% confidence interval of the calibration intercepts and slopes contain the values 0 and 1, respectively., Conclusions: The SOURCE prediction models show fair to good c-indices and an overall good calibration. The models are the first in esophageal and gastric cancer to predict survival at diagnosis for a variety of treatments. Future research is needed to demonstrate their value for shared decision-making in clinical practice.
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- 2021
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31. Outcomes of curative esophageal cancer surgery in elderly: A meta-analysis.
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Baranov NS, Slootmans C, van Workum F, Klarenbeek BR, Schoon Y, and Rosman C
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Background: An increasing number of older patients is undergoing curative, surgical treatment of esophageal cancer. Previous meta-analyses have shown that older patients suffered from more postoperative morbidity and mortality compared to younger patients, which may lead to patient selection based on age. However, only studies including patients that underwent open esophagectomy were included. Therefore, it remains unknown whether there is an association between age and outcome in patients undergoing minimally invasive esophagectomy., Aim: To perform a systematic review on age and postoperative outcome in esophageal cancer patients undergoing esophagectomy., Methods: Studies comparing older with younger patients with primary esophageal cancer undergoing curative esophagectomy were included. Meta-analysis of studies using a 75-year age threshold are presented in the manuscript, studies using other age thresholds in the Supplementary material. MEDLINE, Embase and the Cochrane Library were searched for articles published between 1995 and 2020. Risk of bias was assessed with the Newcastle-Ottawa Scale. Primary outcomes were anastomotic leak, pulmonary and cardiac complications, delirium, 30- and 90-d, and in-hospital mortality. Secondary outcomes included pneumonia and 5-year overall survival., Results: Seven studies (4847 patients) using an age threshold of 75 years were included for meta-analysis with 755 older and 4092 younger patients. Older patients (9.05%) had higher rates of 90-d mortality compared with younger patients (3.92%), (confidence interval = 1.10-5.56). In addition, older patients (9.45%) had higher rates of in-hospital mortality compared with younger patients (3.68%), (confidence interval = 1.01-5.91). In the subgroup of 2 studies with minimally invasive esophagectomy, older and younger patients had comparable 30-d, 90-d and in-hospital mortality rates., Conclusion: Older patients undergoing curative esophagectomy for esophageal cancer have a higher postoperative mortality risk. Minimally invasive esophagectomy may be important for minimizing mortality in older patients., Competing Interests: Conflict-of-interest statement: The authors declare that there is no conflict of interest., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)
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- 2021
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32. Effect of Pneumatic Tube System Transport on Cell-Free DNA.
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Geerlings MJ, Hofste LSM, Kamping EJ, Abdi Z, Tolmeijer SH, Garms LM, Klarenbeek BR, and Ligtenberg MJL
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- Edetic Acid chemistry, Humans, Limit of Detection, Blood Specimen Collection instrumentation, Cell-Free Nucleic Acids blood, Circulating Tumor DNA blood, Esophageal Neoplasms blood
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- 2021
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33. Controlled mechanical ventilation to detect regional lymph node metastases in esophageal cancer using USPIO-enhanced MRI; comparison of image quality.
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de Gouw DJJM, Maas MC, Slagt C, Mühling J, Nakamoto A, Klarenbeek BR, Rosman C, Hermans JJ, and Scheenen TWJ
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- Adult, Aged, Contrast Media, Female, Humans, Lymphatic Metastasis, Male, Mediastinum pathology, Middle Aged, Prospective Studies, Dextrans, Esophageal Neoplasms diagnostic imaging, Esophageal Neoplasms pathology, Magnetic Resonance Imaging methods, Magnetite Nanoparticles, Respiration, Artificial
- Abstract
Background: Artifacts caused by respiratory motion or ventilation-induced chest movements are a major problem for thoracic MRI, as they can obscure important anatomical structures such as lymph node metastases. We compared image quality of routine breathhold with intermittent apnea during controlled mechanical ventilation of patients under general anesthesia as the ideal situation without respiratory motion in the detection and characterization of regional lymph nodes in esophageal cancer., Methods: In this prospective study, 10 patients treated for esophageal cancer underwent ultrasmall superparamagnetic iron oxide (USPIO) enhanced MRI scans. Before neoadjuvant therapy, MRI scans were acquired with a routine breathhold technique. After neoadjuvant therapy, patients were scanned under general anesthesia immediately prior to surgery with controlled mechanical ventilation. The image quality was compared using a Likert scale questionnaire based on visibility of anatomical structures and image artifacts., Results: MRI with controlled mechanical ventilation and prolonged controlled apnea of 4 min was safe and feasible. All cardio-respiratory monitoring parameters remained stable during the apnea phases. Mediastinal and upper abdominal lymph nodes down to 2 mm in size could be visualized with all sequences. All image quality criteria, including visibility of thoracic structures and regional lymph nodes were scored higher using the controlled ventilation sequences compared to the routine breathhold phase., Conclusion: USPIO-enhanced MRI with controlled mechanical ventilation is superior to routine breathhold MRI in visualizing lymph nodes, which warrants new motion reduction techniques to use MRI for the detection of lymph node metastases in patients with esophageal cancer., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2020
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34. Totally minimally invasive esophagectomy versus hybrid minimally invasive esophagectomy: systematic review and meta-analysis.
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van Workum F, Klarenbeek BR, Baranov N, Rovers MM, and Rosman C
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- Esophagectomy adverse effects, Humans, Minimally Invasive Surgical Procedures, Thoracoscopy, Treatment Outcome, Esophageal Neoplasms surgery, Laparoscopy
- Abstract
Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Articles comparing HMIE and TMIE were included. The Newcastle-Ottawa scale was used for critical appraisal of methodological quality. The primary outcome was pneumonia. Sensitivity analysis was performed by analyzing outcome for open chest hybrid MIE versus total TMIE and open abdomen MIE versus TMIE separately. Therefore, subgroup analysis was performed for laparoscopy-assisted HMIE versus TMIE, thoracoscopy-assisted HMIE versus TMIE, Ivor Lewis HMIE versus Ivor Lewis TMIE, and McKeown HMIE versus McKeown TMIE. There were no randomized controlled trials. Twenty-nine studies with a total of 3732 patients were included. Studies had a low to moderate risk of bias. In the main analysis, the pooled incidence of pneumonia was 19.0% after HMIE and 9.8% after TMIE which was not significantly different between the groups (RR: 1.46, 95% CI: 0.97-2.20). TMIE was associated with a lower incidence of wound infections (RR: 1.81, 95% CI: 1.13-2.90) and less blood loss (SMD: 0.78, 95% CI: 0.34-1.22) but with longer operative time (SMD:-0.33, 95% CI: -0.59--0.08). In subgroup analysis, laparoscopy-assisted HMIE was associated with a higher lymph node count than TMIE, and Ivor Lewis HMIE was associated with a lower anastomotic leakage rate than Ivor Lewis TMIE. In general, TMIE was associated with moderately lower morbidity compared to HMIE, but randomized controlled evidence is lacking. The higher leakage rate and lower lymph node count that was found after TMIE in sensitivity analysis indicate that TMIE can also have disadvantages. The findings of this meta-analysis should be considered carefully by surgeons when moving from HMIE to TMIE., (© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2020
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35. Selecting esophageal cancer patients for lymphadenectomy after neoadjuvant chemoradiotherapy: a modeling study.
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Scholte M, de Gouw DJ, Klarenbeek BR, Grutters JP, Rosman C, and Rovers MM
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Objectives: Two-thirds of patients do not harbor lymph node (LN) metastases after neoadjuvant chemoradiotherapy (nCRT). Our aim was to explore under which circumstances a selective lymph node dissection (LND) strategy, which selects patients for LND based on the restaging results after nCRT, has added value compared with standard LND in esophageal cancer., Design: A decision tree with state-transition model was developed. Input data on short-term and long-term consequences were derived from literature. Sensitivity analyses were conducted to assess promising scenarios and uncertainty., Setting: Dutch healthcare system., Participants: Hypothetical cohort of esophageal cancer patients who have already received nCRT and are scheduled for esophagectomy., Interventions: A standard LND cohort was compared with a cohort of patients that received selective LND based on the restaging results after nCRT., Main Outcome Measures: Quality-adjusted life years (QALYs), residual LN metastases and LND-related complications., Results: Selective LND could have short-term benefits, that is, a decrease in the number of performed LNDs and LND-related complications. However, this may not outweigh a slight increase in residual LN metastases which negatively impacts QALYs in the long-term. To accomplish equal QALYs as with standard LND, a new surgical strategy should have the same or higher treatment success rate as standard LND, that is, should show equal or less recurrences due to residual LN metastases., Conclusions: The reduction in LND-related complications that is accomplished by selecting patients for LND based on restaging results after nCRT seems not to outweigh a QALY loss in the long-term due to residual LN metastases. Despite the short-term advantages of selective LND, this strategy can only match long-term QALYs of standard LND when its success rate equals the success rate of standard LND., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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36. A systematic review and meta-analysis of disease severity and risk of recurrence in young versus elderly patients with left-sided acute diverticulitis.
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van Dijk ST, Abdulrahman N, Draaisma WA, van Enst WA, Puylaert JBCM, de Boer MGJ, Klarenbeek BR, Otte JA, Felt-Bersma RJF, van Geloven AAW, and Boermeester MA
- Subjects
- Acute Disease, Adult, Age Factors, Aged, Disease Progression, Humans, Middle Aged, Recurrence, Risk Factors, Severity of Illness Index, Tomography, X-Ray Computed, Diverticulitis, Colonic diagnostic imaging, Diverticulitis, Colonic epidemiology, Diverticulitis, Colonic therapy
- Abstract
Young patients are thought to have a more severe disease course and a higher rate of recurrent diverticulitis. However, these understandings are mainly based on studies with important limitations. This review aimed to clarify the true natural history of acute diverticulitis in young patients compared to elderly patients. PubMed and MEDLINE were searched for studies reporting outcomes on disease severity or recurrences in young and elderly patients with a computed tomography-proven diagnosis of acute diverticulitis. Twenty-seven studies were included. The proportion of complicated diverticulitis at presentation (21 studies) was not different for young patients (age cut-off 40-50 years) compared to elderly patients [risk ratio (RR) 1.19; 95% confidence interval 0.94-1.50]. The need for emergency surgery (11 studies) or percutaneous abscess drainage (two studies) yielded comparable results for both groups with a RR of 0.93 (95% confidence interval 0.70-1.24) and 1.65 (95% confidence interval 0.60-4.57), respectively. Crude data on recurrent diverticulitis rates (12 studies) demonstrated a significantly higher RR of 1.47 (95% confidence interval 1.20-1.80) for young patients. Notably, no association between age and recurrent diverticulitis was found in the studies that used survival analyses, taking length of follow-up per age group into account. In conclusion, young patients do not have a more severe course of acute diverticulitis. Published data on the risk of recurrent diverticulitis in young patients are conflicting, but those with the most robust design do not demonstrate an increased risk. Therefore, young patients should not be treated more aggressively nor have a lower threshold for elective surgery just because of their age.
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- 2020
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37. Extent and consequences of lymphadenectomy in oesophageal cancer surgery: case vignette survey.
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de Gouw DJ, Scholte M, Gisbertz SS, Wijnhoven BPL, Rovers MM, Klarenbeek BR, and Rosman C
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Objectives: Lymph node dissection (LND) is part of the standard operating procedure in patients with resectable oesophageal cancer after neoadjuvant chemoradiotherapy regardless of lymph node (LN) status. The aims of this case vignette survey were to acquire expert opinions on the current practice of LND and to determine potential consequences of non-invasive LN staging on the extent of LND and postoperative morbidity., Design: An online survey including five short clinical cases (case vignettes) was sent to 272 oesophageal surgeons worldwide., Participants: 86 oesophageal surgeons (median experience in oesophageal surgery of 15 years) participated in the survey (response rate 32%)., Main Outcome Measures: Extent of standard LND, potential changes in LND based on accurate LN staging and consequences for postoperative morbidity were evaluated., Results: Standard LND varied considerably between experts; for example, pulmonary ligament, splenic artery, aortopulmonary window and paratracheal LNs are routinely dissected in less than 60%. The omission of (parts of) LND is expected to decrease the number of chyle leakages, pneumonias, and laryngeal nerve pareses and to reduce operating time. In order to guide surgical treatment decisions, a diagnostic test for LN staging after neoadjuvant therapy requires a minimum sensitivity of 92% and a specificity of 90%., Conclusions: This expert case vignette survey study shows that there is no consensus on the extent of standard LND. Oesophageal surgeons seem more willing to extend LND rather than omit LND, based on accurate LN staging. The majority of surgeons expect that less extensive LND can reduce postoperative morbidity., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2020
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38. Functional complaints and quality of life after transanal total mesorectal excision: a meta-analysis.
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van der Heijden JAG, Koëter T, Smits LJH, Sietses C, Tuynman JB, Maaskant-Braat AJG, Klarenbeek BR, and de Wilt JHW
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- Fecal Incontinence etiology, Female, Humans, Laparoscopy adverse effects, Postoperative Complications, Proctectomy adverse effects, Rectal Neoplasms physiopathology, Rectum physiopathology, Sexual Dysfunction, Physiological etiology, Transanal Endoscopic Surgery adverse effects, Treatment Outcome, Laparoscopy methods, Proctectomy methods, Quality of Life, Rectal Neoplasms surgery, Rectum surgery, Transanal Endoscopic Surgery methods
- Abstract
Background: Total mesorectal excision (TME) gives excellent oncological results in rectal cancer treatment, but patients may experience functional problems. A novel approach to performing TME is by single-port transanal minimally invasive surgery. This systematic review evaluated the functional outcomes and quality of life after transanal and laparoscopic TME., Methods: A comprehensive search in PubMed, the Cochrane Library, Embase and the trial registers was conducted in May 2019. PRISMA guidelines were used. Data for meta-analysis were pooled using a random-effects model., Results: A total of 11 660 studies were identified, from which 14 studies and six conference abstracts involving 846 patients (599 transanal TME, 247 laparoscopic TME) were included. A substantial number of patients experienced functional problems consistent with low anterior resection syndrome (LARS). Meta-analysis found no significant difference in major LARS between the two approaches (risk ratio 1·13, 95 per cent c.i. 0·94 to 1·35; P = 0·18). However, major heterogeneity was present in the studies together with poor reporting of functional baseline assessment., Conclusion: No differences in function were observed between transanal and laparoscopic TME., (© 2020 BJS Society Ltd published by John Wiley & Sons Ltd.)
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- 2020
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39. Identifying Biomarkers in Lymph Node Metastases of Esophageal Adenocarcinoma for Tumor-Targeted Imaging.
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de Gouw DJJM, Rijpkema M, de Bitter TJJ, Baart VM, Sier CFM, Hernot S, van Dam GM, Nagtegaal ID, Klarenbeek BR, Rosman C, and van der Post RS
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- Adenocarcinoma diagnosis, Aged, Aged, 80 and over, Carbonic Anhydrase IX metabolism, Carcinoembryonic Antigen metabolism, Case-Control Studies, Epithelial Cell Adhesion Molecule metabolism, Esophageal Neoplasms diagnosis, Female, Gene Expression Regulation, Neoplastic, Humans, Male, Middle Aged, Molecular Imaging, Mucin-1 metabolism, Vascular Endothelial Growth Factor A metabolism, Adenocarcinoma metabolism, Biomarkers, Tumor metabolism, Esophageal Neoplasms metabolism, Lymphatic Metastasis diagnosis, Tissue Array Analysis methods
- Abstract
Introduction: Tumor-targeted imaging is a promising technique for the detection of lymph node metastases (LNM) and primary tumors. It remains unclear which biomarker is the most suitable target to distinguish malignant from healthy tissue in esophageal adenocarcinoma (EAC)., Objective: We performed an immunohistochemistry study to identify viable tumor markers for tumor-targeted imaging of EAC., Methods: We used samples from 72 patients with EAC to determine the immunohistochemical expression of ten potential tumor biomarkers for EAC (carbonic anhydrase IX [CA-IX], carcinoembryonic antigen [CEA], hepatic growth factor receptor, epidermal growth factor receptor, epithelial membrane antigen [EMA], epithelial cell adhesion molecule [EpCAM], human epidermal growth factor receptor 2 [HER-2], urokinase plasminogen activator receptor, vascular endothelial growth factor-A [VEGF-A], and VEGF receptor 2). Immunohistochemistry was performed on tissue microarrays of LNM (n = 48), primary EACs (n = 62), fibrotic tissues (n = 11), nonmalignant lymph nodes (n = 24), and normal esophageal and gastric tissues (n = 40). Tumor marker staining was scored on intensity and percentage of positive cells., Results: EMA and EpCAM showed strong expression in LNM (> 95%) and primary EACs (> 95%). Significant expression was also observed for LNM and EAC using VEGF-A (85 and 92%), CEA (68 and 54%), and CA-IX (4 and 34%). The other tumor biomarkers showed expression of 0-15% for LNM and primary EAC. Except for VEGF-A, nonmalignant lymph node staining was scored as slight or absent., Conclusions: High expression rates and correlation between LNM in EAC combined with low expression rates in healthy lymph nodes and esophagus tissues were observed for EpCAM and CEA, meaning these are promising targets for tumor-targeted imaging approaches for lymph nodes in patients with EAC.
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- 2020
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40. Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial).
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Kalkdijk-Dijkstra AJ, van der Heijden JAG, van Westreenen HL, Broens PMA, Trzpis M, Pierie JPEN, and Klarenbeek BR
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- Humans, Cost-Benefit Analysis, Health Care Costs, Netherlands, Quality of Life, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Fecal Incontinence economics, Fecal Incontinence physiopathology, Fecal Incontinence psychology, Fecal Incontinence rehabilitation, Pelvic Floor, Physical Therapy Modalities, Postoperative Complications economics, Postoperative Complications physiopathology, Postoperative Complications psychology, Postoperative Complications rehabilitation, Proctectomy, Rectal Neoplasms surgery
- Abstract
Background: After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment., Methods: The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes., Discussion: The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial., Trial Registration: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.
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- 2020
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41. Meta-analysis of the role of colonoscopy after an episode of left-sided acute diverticulitis.
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Rottier SJ, van Dijk ST, van Geloven AAW, Schreurs WH, Draaisma WA, van Enst WA, Puylaert JBCM, de Boer MGJ, Klarenbeek BR, Otte JA, Felt RJF, and Boermeester MA
- Subjects
- Acute Disease, Colorectal Neoplasms diagnostic imaging, Colorectal Neoplasms epidemiology, Diverticulitis diagnostic imaging, Humans, Prevalence, Tomography, X-Ray Computed, Colonoscopy, Colorectal Neoplasms diagnosis, Diverticulitis therapy
- Abstract
Background: Routine colonoscopy was traditionally recommended after acute diverticulitis to exclude coexistent malignancy. Improved CT imaging may make routine colonoscopy less required over time but most guidelines still recommend it. The aim of this review was to assess the role of colonoscopy in patients with CT-proven acute diverticulitis., Methods: PubMed and Embase were searched for studies reporting the prevalence of advanced colorectal neoplasia (ACN) or colorectal carcinoma in patients who underwent colonoscopy within 1 year after CT-proven left-sided acute diverticulitis. The prevalence was pooled using a random-effects model and, if possible, compared with that among asymptomatic controls., Results: Seventeen studies with 3296 patients were included. The pooled prevalence of ACN was 6·9 (95 per cent c.i. 5·0 to 9·4) per cent and that of colorectal carcinoma was 2·1 (1·5 to 3·1) per cent. Only two studies reported a comparison with asymptomatic controls, showing comparable risks (risk ratio 1·80, 95 per cent c.i. 0·66 to 4·96). In subgroup analysis of patients with uncomplicated acute diverticulitis, the prevalence of colorectal carcinoma was only 0·5 (0·2 to 1·2) per cent., Conclusion: Routine colonoscopy may be omitted in patients with uncomplicated diverticulitis if CT imaging is otherwise clear. Patients with complicated disease or ongoing symptoms should undergo colonoscopy., (© 2019 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.)
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- 2019
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42. Detecting Pathological Complete Response in Esophageal Cancer after Neoadjuvant Therapy Based on Imaging Techniques: A Diagnostic Systematic Review and Meta-Analysis.
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de Gouw DJJM, Klarenbeek BR, Driessen M, Bouwense SAW, van Workum F, Fütterer JJ, Rovers MM, Ten Broek RPG, and Rosman C
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- Esophageal Neoplasms therapy, Humans, Prognosis, Diagnostic Imaging methods, Esophageal Neoplasms diagnostic imaging, Esophageal Neoplasms pathology, Multimodal Imaging methods, Neoadjuvant Therapy methods
- Abstract
Introduction: Up to 32% of patients with esophageal cancer show a pathological complete response (ypCR) after neoadjuvant therapy. To prevent overtreatment, the indication to perform esophagectomy in these patients should be reconsidered. Implementing an organ-preserving strategy for patients with ypCR requires an accurate assessment of residual disease after neoadjuvant treatment. The aim of this study was to systematically review the effectiveness of imaging techniques used for detection of ypCR after neoadjuvant therapy but before resection in patients with esophageal cancer., Methods: A systematic literature search of the Medline, Embase, and Cochrane Library databases was performed from January 1, 2000, to December 13, 2017. Eligible studies were diagnostic studies that compared results of imaging modalities after neoadjuvant therapy to histopathological findings in the resection specimen after esophagectomy. Methodological quality was assessed by the Cochrane Quality Assessment of Diagnostic Accuracy Studies, version 2, model. Primary outcome measures were true positive, false-positive, false-negative, and true negative values of imaging techniques predicting ypCR. A meta-analysis was performed by pooling sensitivities and specificities by using a bivariate model., Results: A total of 4420 articles were identified. After exclusion of irrelevant titles and abstracts, 360 articles were reviewed in full text. In total, four imaging modalities (computed tomography [CT], positron emission tomography [PET-CT], endoscopic ultrasound [EUS], and magnetic resonance imaging [MRI]) were used for restaging. The meta-analysis was conducted with data from 56 studies involving 3625 patients. The pooled sensitivities of CT, PET-CT, EUS, and MRI for detecting ypCR were 0.35, 0.62, 0.01 and 0.80, respectively, whereas the pooled specificities were 0.83, 0.73, 0.99, and 0.83, respectively. The positive predictive value in detecting ypCR was 0.47 for CT, 0.41 for PET-CT, not applicable for EUS, and 0.61 for MRI., Conclusion: Current imaging modalities such as CT, PET-CT, and EUS seem to be insufficiently accurate to identify complete responders. More accurate diagnostic tests are needed to improve restaging accuracy for patients with esophageal cancer., (Copyright © 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)
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- 2019
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43. A systematic review and meta-analysis of outpatient treatment for acute diverticulitis.
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van Dijk ST, Bos K, de Boer MGJ, Draaisma WA, van Enst WA, Felt RJF, Klarenbeek BR, Otte JA, Puylaert JBCM, van Geloven AAW, and Boermeester MA
- Subjects
- Abscess therapy, Acute Disease, Digestive System Surgical Procedures, Diverticulitis economics, Diverticulitis surgery, Drainage, Emergencies, Humans, Inpatients, Patient Readmission, Diverticulitis therapy, Outpatients
- Abstract
Background: The shift from routine antibiotics towards omitting antibiotics for uncomplicated acute diverticulitis opens up the possibility for outpatient instead of inpatient treatment, potentially reducing the burden of one of the most common gastrointestinal diseases in the Western world., Purpose: Assessing the safety and cost savings of outpatient treatment in acute colonic diverticulitis., Methods: PubMed and EMBASE were searched for studies on outpatient treatment of colonic diverticulitis, confirmed with computed tomography or ultrasound. Outcomes were readmission rate, need for emergency surgery or percutaneous abscess drainage, and healthcare costs., Results: A total of 19 studies with 2303 outpatient treated patients were included. These studies predominantly excluded patients with comorbidity or immunosuppression, inability to tolerate oral intake, or lack of an adequate social network. The pooled incidence rate of readmission for outpatient treatment was 7% (95%CI 6-9%, I
2 48%). Only 0.2% (2/1288) of patients underwent emergency surgery, and 0.2% (2/1082) of patients underwent percutaneous abscess drainage. Only two studies compared readmission rates outpatients that had similar characteristics as a control group of inpatients; 4.5% (3/66) and 6.3% (2/32) readmissions in outpatient groups versus 6.1% (4/66) and 0.0% (0/44) readmissions in inpatient groups (p = 0.619 and p = 0.174, respectively). Average healthcare cost savings for outpatient compared with inpatient treatment ranged between 42 and 82%., Conclusion: Outpatient treatment of uncomplicated diverticulitis resulted in low readmission rates and very low rates of complications. Furthermore, healthcare cost savings were substantial. Therefore, outpatient treatment of uncomplicated diverticulitis seems to be a safe option for most patients.- Published
- 2018
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44. McKeown or Ivor Lewis totally minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction: systematic review and meta-analysis.
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van Workum F, Berkelmans GH, Klarenbeek BR, Nieuwenhuijzen GAP, Luyer MDP, and Rosman C
- Abstract
Background: Minimally invasive esophagectomy (MIE) has consistently been associated with improved perioperative outcome and similar oncological safety compared to open esophagectomy. However, it is currently unclear what type of MIE is preferred for patients with resectable esophageal cancer., Methods: Literature was searched in Medline, Embase and the Cochrane library combining relevant search terms. Articles that included patients undergoing totally minimally invasive esophagectomy (TMIE) or hybrid minimally invasive esophagectomy (HMIE) and compared McKeown with Ivor Lewis procedures were included. Studies were excluded if they included >10% of patients undergoing a procedure other than MIE McKeown or MIE Ivor Lewis (i.e., transhiatal resections). The primary outcome parameter was anastomotic leakage. Secondary outcome parameters were: other complications, reinterventions, reoperations, hospital length of stay, ICU length of stay, postoperative mortality, operative time, blood loss, R0 resection rate, lymph nodes examined, quality of life and costs., Results: Five studies with a total of 1,681 patients undergoing TMIE were included. There were no studies comparing HMIE McKeown versus HMIE Ivor Lewis. There were no randomized controlled trials and all included studies were cohort studies with a moderate risk of bias. No meta-analysis could be performed for R0 resection rate, survival, quality of life and costs because there was insufficient data available for these parameters. The incidence of anastomotic leakage did not differ between the groups [relative risk (RR) =1.39, 95% confidence interval (CI) =0.90-10.38, P=0.14]. TMIE Ivor Lewis was associated with a lower incidence of recurrent laryngeal nerve (RLN) trauma (RR =6.70, 95% CI =3.09-14.55, P<0.001), a shorter hospital length of stay [standardized mean difference (SMD) =0.17, 95% CI =0.06-0.28, P=0.002] and less blood loss (SMD =0.69, 95% CI =0.25-1.12, P=0.002)., Conclusions: TMIE Ivor Lewis is associated with improved outcome regarding RLN trauma, hospital length of stay and blood loss as compared to TMIE-McKeown, but the incidence of anastomotic leakage is not different. The evidence is limited, of low quality and at risk for bias. A randomized controlled trial is currently being performed in order to demonstrate whether a McKeown or Ivor Lewis procedure should be preferred in patients undergoing MIE., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.
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- 2017
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45. Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.
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van Workum F, Bouwense SA, Luyer MD, Nieuwenhuijzen GA, van der Peet DL, Daams F, Kouwenhoven EA, van Det MJ, van den Wildenberg FJ, Polat F, Gisbertz SS, Henegouwen MI, Heisterkamp J, Langenhoff BS, Martijnse IS, Grutters JP, Klarenbeek BR, Rovers MM, and Rosman C
- Subjects
- Anastomosis, Surgical adverse effects, Cost-Benefit Analysis, Data Collection, Esophagectomy adverse effects, Humans, Quality of Life, Anastomosis, Surgical methods, Clinical Protocols, Esophageal Neoplasms surgery, Esophagectomy methods, Minimally Invasive Surgical Procedures methods
- Abstract
Background: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE., Methods/design: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness., Discussion: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness., Trial Registration: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.
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- 2016
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46. Review of current classifications for diverticular disease and a translation into clinical practice.
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Klarenbeek BR, de Korte N, van der Peet DL, and Cuesta MA
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- Diverticulitis diagnostic imaging, Diverticulitis pathology, Diverticulitis therapy, Humans, Tomography, X-Ray Computed, Diverticulitis classification, Translational Research, Biomedical
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Introduction: Diverticular disease of the sigmoid colon prevails in Western society. Its presentation may vary greatly per individual patient, from symptomatic diverticulosis to perforated diverticulitis. Since publication of the original Hinchey classification, several modifications and new grading systems have been developed. Yet, new insights in the natural history of the disease, the emergence of the computed tomography scan, and new treatment modalities plead for evolving classifications., Methods: This article reviews all current classifications for diverticular disease., Result: A three-stage model is advanced for a renewed and comprehensive classification system for diverticular disease, incorporating up-to-date imaging and treatment modalities.
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- 2012
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47. Management of diverticulitis: results of a survey among gastroenterologists and surgeons.
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de Korte N, Klarenbeek BR, Kuyvenhoven JP, Roumen RM, Cuesta MA, and Stockmann HB
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- Ambulatory Care, Analgesics, Non-Narcotic therapeutic use, Anti-Bacterial Agents therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Chi-Square Distribution, Colectomy, Colonoscopy, Diet, Diverticulitis, Colonic diagnostic imaging, Humans, Netherlands, Practice Guidelines as Topic, Severity of Illness Index, Tomography, X-Ray Computed, Ultrasonography, Diverticulitis, Colonic therapy, Gastroenterology statistics & numerical data, General Surgery statistics & numerical data, Guideline Adherence, Practice Patterns, Physicians' statistics & numerical data
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Aim: The study aimed to investigate current management strategies for left-sided diverticulitis and compare them with current international guidelines. Differences between surgeons and gastroenterologists and between gastrointestinal and nongastrointestinal surgeons were assessed., Method: A web-based survey of treatment options for uncomplicated and complicated diverticulitis was carried out among surgeons and gastroenterologists in the Netherlands. Only surgeons were asked about surgical strategy., Results: A total of 292 surgeons and 87 gastroenterologists responded, representing 92% of all surgical and 46% of all gastroenterology departments. Ninety per cent of respondents treated mild diverticulitis without antibiotics. About one-fifth (18% gastroenterologists; 19% surgeons) regarded a CT scan as mandatory in the initial assessment. Most surgeons and gastroenterologists used some form of bowel rest, would consider outpatient treatment and would perform a colonoscopy on follow up. For Hinchey Stage 3, 78% of surgeons would consider resection and primary anastomosis and laparoscopic lavage was viewed as a valid alternative by 30% of gastrointestinal and 2% of nongastrointestinal surgeons. For Hinchey stage 4, 46% of gastrointestinal and 72% of nongastrointestinal surgeons would always perform Hartmann's procedure., Conclusion: The treatment of diverticulitis in the Netherlands shows major differences when compared with guidelines for all stages of disease., (© 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.)
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- 2011
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48. Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial.
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Klarenbeek BR, Bergamaschi R, Veenhof AA, van der Peet DL, van den Broek WT, de Lange ES, Bemelman WA, Heres P, Lacy AM, and Cuesta MA
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- Comorbidity, Double-Blind Method, Elective Surgical Procedures statistics & numerical data, Follow-Up Studies, Humans, Ileostomy methods, Laparoscopy statistics & numerical data, Laparotomy methods, Laparotomy statistics & numerical data, Postoperative Complications epidemiology, Postoperative Complications surgery, Prospective Studies, Quality of Life, Recovery of Function, Recurrence, Time Factors, Diverticulitis, Colonic surgery, Diverticulosis, Colonic surgery, Laparoscopy methods, Sigmoid Diseases surgery
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Background: The short-term results of the Sigma trial show that laparoscopic sigmoid resection (LSR) used electively for diverticular disease offers advantages over open sigmoid resection (OSR). This study aimed to compare the overall mortality and morbidity rates after evaluation of the clinical outcomes at the 6-month follow-up evaluation., Methods: In a prospective, multicenter, double-blind, parallel-arm, randomized control trial, eligible patients were randomized to either LSR or OSR. The short-term results and methodologic details have been published previously. Follow-up evaluation was performed at the outpatient clinic 6 weeks and 6 months after surgery., Results: In this trial, 104 patients were randomized for either LSR or OSR, and the conversion rate was 19.2%. The LSR approach was associated with short-term benefits such as a 15.4% reduction in the major complications rate, less pain, and a shorter hospital stay at the cost of a longer operating time. At the 6-month follow-up evaluation, no significant differences in morbidity or mortality rates were found. Two patients died of cardiac causes (overall mortality, 3%). Late complications (7 LSR vs. 12 OSR; p = 0.205) consisted of three incisional hernias, five small bowel obstructions, four enterocutaneous fistulas, one intraabdominal abscess, one retained gauze, two anastomotic strictures, and three recurrent episodes of diverticulitis. Nine of these patients underwent additional surgical interventions. Consideration of the major morbidity over the total follow-up period (0-6 months) shows that the LSR patients experienced significantly fewer complications than the OSR patients (9 LSR vs. 23 OSR; p = 0.003). The Short Form-36 (SF-36) questionnaire showed significantly better quality of life for LSR at the 6-week follow-up assessment. However, at the 6-month follow-up assessment, these differences were decreased., Conclusions: The late clinical outcomes did not differ between LSR and OSR during the 30-day to 6-month follow-up period. Consideration of total postoperative morbidity shows a 27% reduction in major morbidity for patients undergoing laparoscopic surgery for diverticular disease.
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- 2011
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49. The cost effectiveness of elective laparoscopic sigmoid resection for symptomatic diverticular disease: financial outcome of the randomized control Sigma trial.
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Klarenbeek BR, Coupé VM, van der Peet DL, and Cuesta MA
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- Allied Health Personnel economics, Blood Transfusion economics, Cost-Benefit Analysis, Costs and Cost Analysis, Diagnostic Imaging economics, Direct Service Costs statistics & numerical data, Emergency Medical Services economics, Health Care Costs, Hospital Costs statistics & numerical data, Hospitalization economics, Humans, Laparotomy economics, Personnel, Hospital economics, Postoperative Complications economics, Postoperative Complications epidemiology, Preoperative Care economics, Diverticulitis surgery, Diverticulum, Colon surgery, Elective Surgical Procedures economics, Laparoscopy economics, Randomized Controlled Trials as Topic statistics & numerical data, Sigmoid Diseases surgery
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Background: Direct healthcare costs of patients with symptomatic diverticular disease randomized for either laparoscopic or open elective sigmoid resection are compared. Cost-effectiveness analysis of the laparoscopic approach compared with open sigmoid resections is presented., Methods: An economic evaluation of the randomized control Sigma trial was conducted, comparing elective laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) in patients with symptomatic diverticulitis. Prospective registration of detailed intervention units per patient resulted in actual resource use per individual patient. To avoid distributional assumptions, the nonparametric bootstrap was applied. For the cost-effectiveness analysis, differences in total cost between LSR and OSR were compared with the differences in VAS pain score, SF-36 values for general health, and complication rate., Results: The difference in total healthcare costs between the group that received LSR (euro 9969) and the group that received OSR (euro 9366) was not statistically significant. The slight increase in total costs was determined mainly by the significantly higher operation costs of LSR (euro 6663 vs. euro 5306). Lower costs for hospitalization (euro 2983 vs. euro 3598), blood products (euro 87 vs. euro 240), paramedical services (euro 157 vs. euro 278), and emergency attendance (euro 72 vs. euro 115) in the LSR group partially compensated these increased operation costs. The incremental cost-effectiveness ratios (ICER) indicate that improvements in pain, quality of life, and complication rate could be achieved at limited costs., Conclusion: Total healthcare costs of laparoscopic and open elective sigmoid resections for symptomatic diverticular disease are similar. As the clinical outcomes are in favor of the LSR group, candidates for an elective sigmoid resection should preferably be approached laparoscopically.
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- 2011
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50. Current surgical treatment of diverticular disease in The Netherlands.
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Morks AN, Klarenbeek BR, Flikweert ER, van der Peet DL, Karsten TM, Eddes EH, Cuesta MA, and de Graaf PW
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- Adult, Aged, Aged, 80 and over, Databases, Factual, Digestive System Surgical Procedures adverse effects, Digestive System Surgical Procedures methods, Diverticulitis diagnosis, Diverticulum diagnosis, Female, Humans, Male, Middle Aged, Netherlands, Postoperative Complications etiology, Diverticulitis surgery, Diverticulum surgery
- Abstract
Aim: To evaluate the development of diagnostic tools, indications for surgery and treatment modalities concerning diverticular disease (DD) in The Netherlands., Methods: Data were collected from 100 patients who underwent surgery for DD in three Dutch hospitals. All hospitals used the same standardized database. The collected data included patient demographics, patient history, type of surgery and complications. Patients were divided into two groups, one undergoing elective surgery (elective group) and the other undergoing acute surgery (acute group)., Results: Two hundred and ninety-nine patients were admitted between 2000 and 2007. One hundred and seventy-eight patients underwent acute surgery and 121 patients received elective operations. The median age of the 121 patients was 69 years (range: 28-94 years), significantly higher in acute patients (P = 0.010). Laparoscopic resection was performed in 31% of elective patients. In the acute setting, 61% underwent a Hartmann procedure. The overall morbidity and mortality were 51% and 10%, and 60% and 16% in the acute group, which were significantly higher than in the elective group (36% and 1%). Only 35% of the temporary ostomies were restored., Conclusion: This study gives a picture of current surgical practice for DD in The Netherlands. New developments are implemented in daily practice, resulting in acceptable morbidity and mortality rates.
- Published
- 2010
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