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BACKGROUND: The role of laparoscopy for emergency resection of left-sided obstructive colon cancer remains unclear, especially regarding impact on survival. OBJECTIVE: This study aimed to determine short- and long-term outcomes after laparoscopic versus open emergency resection of left-sided obstructive colon cancer. DESIGN: This observational cohort study compared patients who underwent laparoscopic emergency resection to those who underwent open emergency resection between 2009 and 2016 by using 1:3 propensity-score matching. Matching variables included sex, age, BMI, ASA score, previous abdominal surgery, tumor location, cT4, cM1, multivisceral resection, small-bowel distention on CT, and subtotal colectomy. SETTING: This was a nationwide, population-based study. PATIENTS: Of 2002 eligible patients with left-sided obstructive colon cancer, 158 patients who underwent laparoscopic emergency resection were matched with 474 patients who underwent open emergency resection. INTERVENTIONS: The intervention was laparoscopic versus open emergency resection. MAIN OUTCOME MEASURES: The main outcome measures were 90-day mortality, 90-day complications, permanent stoma, disease recurrence, overall survival, and disease-free survival. RESULTS: Intentional laparoscopy resulted in significantly fewer 90-day complications (26.6% vs 38.4%; conditional OR, 0.59; 95% CI, 0.39-0.87) and similar 90-day mortality. Laparoscopy resulted in better 3-year overall survival (81.0% vs 69.4%; HR, 0.54; 95% CI, 0.37-0.79) and disease-free survival (68.3% vs 52.3%; HR, 0.64; 95% CI, 0.47-0.87). Multivariable regression analyses of the unmatched 2002 patients confirmed an independent association of laparoscopy with fewer 90-day complications and better 3-year survival. LIMITATIONS: Selection bias was the limitation that cannot be completely ruled out because of the retrospective nature of this study. CONCLUSIONS: This population-based study with propensity score-matched analysis suggests that intentional laparoscopic emergency resection might improve outcomes in patients with left-sided obstructive colon cancer compared to open emergency resection. Management of those patients in the emergency setting requires proper selection for intentional laparoscopic resection if relevant expertise is available, thereby considering other alternatives to avoid open emergency resection (ie, decompressing stoma).

Introduction: Oncological outcome might be influenced by the type of resection in total mesorectal excision (TME) for rectal cancer. The aim was to see if non-restorative LAR would have worse oncological outcome. A comparison was made between non-restorative low anterior resection (NRLAR), restorative low anterior resection (RLAR) and abdominoperineal resection (APR). Materials and methods: This retrospective cohort included data from patients undergoing TME for rectal cancer between 2015 and 2017 in eleven Dutch hospitals. A comparison was made for each different type of procedure (APR, NRLAR or RLAR). Primary outcome was 3-year overall survival (OS). Secondary outcomes included 3-year disease-free survival (DFS) and 3-year local recurrence (LR) rate. Results: Of 998 patients 363 underwent APR, 132 NRLAR and 503 RLAR. Three-year OS was worse after NRLAR (78.2%) compared to APR (86.3%) and RLAR (92.2%, p < 0.001). This was confirmed in a multivariable Cox regression analysis (HR 1.85 (1.07, 3.19), p = 0.03). The 3-year DFS was also worse after NRLAR (60.3%), compared to APR (70.5%) and RLAR (80.1%, p < 0.001), HR 2.05 (1.42, 2.97), p < 0.001. The LR rate was 14.6% after NRLAR, 5.2% after APR and 4.8% after RLAR (p = 0.005), HR 3.22 (1.61, 6.47), p < 0.001. Conclusion: NRLAR might be associated with worse 3-year OS, DFS and LR rate compared to RLAR and APR.

Background Quality of surgery has substantial impact on both short- and long-term clinical outcomes. This stresses the need for objective surgical quality assessment (SQA) for education, clinical practice and research purposes. The aim of this systematic review was to provide a comprehensive overview of all video-based objective SQA tools in laparoscopic procedures and their validity to objectively assess surgical performance. Methods PubMed, Embase.com and Web of Science were systematically searched by two reviewers to identify all studies focusing on video-based SQA tools of technical skills in laparoscopic surgery performed in a clinical setting. Evidence on validity was evaluated using a modified validation scoring system. Results Fifty-five studies with a total of 41 video-based SQA tools were identified. These tools were used in 9 different fields of laparoscopic surgery and were divided into 4 categories: the global assessment scale (GAS), the error-based assessment scale (EBAS), the procedure-specific assessment tool (PSAT) and artificial intelligence (AI). The number of studies focusing on these four categories were 21, 6, 31 and 3, respectively. Twelve studies validated the SQA tool with clinical outcomes. In 11 of those studies, a positive association between surgical quality and clinical outcomes was found. Conclusion This systematic review included a total of 41 unique video-based SQA tools to assess surgical technical skills in various domains of laparoscopic surgery. This study suggests that validated SQA tools enable objective assessment of surgical performance with relevance for clinical outcomes, which can be used for training, research and quality improvement programs.

Background: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. Methods: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1–2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. Findings: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11–22) before surgery for intravenous iron and 19 days (IQR 13–27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55–2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87–4·58]; p

Background Laparoscopic, robot-assisted, and transanal total mesorectal excision are the minimally invasive techniques used most for rectal cancer surgery. Because data regarding oncologic results are lacking, this study aimed to compare these three techniques while taking the learning curve into account. Methods This retrospective population-based study cohort included all patients between 2015 and 2017 who underwent a low anterior resection at 11 dedicated centers that had completed the learning curve of the specific technique. The primary outcome was overall survival (OS) during a 3-year follow-up period. The secondary outcomes were 3-year disease-free survival (DFS) and 3-year local recurrence rate. Statistical analysis was performed using Cox-regression. Results The 617 patients enrolled in the study included 252 who underwent a laparoscopic resection, 205 who underwent a robot-assisted resection, and 160 who underwent a transanal low anterior resection. The oncologic outcomes were equal between the three techniques. The 3-year OS rate was 90% for laparoscopic resection, 90.4% for robot-assisted resection, and 87.6% for transanal low anterior resection. The 3-year DFS rate was 77.8% for laparoscopic resection, 75.8% for robot-assisted resection, and 78.8% for transanal low anterior resection. The 3-year local recurrence rate was in 6.1% for laparoscopic resection, 6.4% for robot-assisted resection, and 5.7% for transanal procedures. Cox-regression did not show a significant difference between the techniques while taking confounders into account. Conclusion The oncologic results during the 3-year follow-up were good and comparable between laparoscopic, robot-assisted, and transanal total mesorectal technique at experienced centers. These techniques can be performed safely in experienced hands.

The aim of this study was to evaluate the safety and efficacy of a modified CAL-WR.The use of segmental colectomy in patients with endoscopically unresectable colonic lesions results in significant morbidity and mortality. CAL-WR is an alternative procedure that may reduce morbidity.This prospective multicenter study was performed in 13 Dutch hospitals between January 2017 and December 2019. Inclusion criteria were (1) colonic lesions inaccessible using current endoscopic resection techniques (judged by an expert panel), (2) non-lifting residual/recurrent adenomatous tissue after previous polypectomy or (3) an undetermined resection margin after endoscopic removal of a low-risk pathological T1 (pT1) colon carcinoma. Thirty-day morbidity, technical success rate and radicality were evaluated.Of the 118 patients included (56% male, mean age 66 years, standard deviation ± 8 years), 66 (56%) had complex lesions unsuitable for endoscopic removal, 34 (29%) had non-lifting residual/recurrent adenoma after previous polypectomy and 18 (15%) had uncertain resection margins after polypectomy of a pT1 colon carcinoma. CAL-WR was technically successful in 93% and R0 resection was achieved in 91% of patients. Minor complications (Clavien-Dindo i-ii) were noted in 7 patients (6%) and an additional oncologic segmental resection was performed in 12 cases (11%). Residual tissue at the scar was observed in 5% of patients during endoscopic follow-up.CAL-WR is an effective, organ-preserving approach that results in minor complications and circumvents the need for major surgery. CAL-WR, therefore, deserves consideration when endoscopic excision of circumscribed lesions is impossible or incomplete.

Objective The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. Summary of background data The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. Methods Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. Results For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. Conclusion Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory. Trial registration Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

Contains fulltext : 249895.pdf (Publisher’s version ) (Open Access) AIM: The aim of this study was to evaluate interobserver variability between individual pathologists and a panel of pathologists in the histopathological assessment of advanced colorectal neoplasms in the Dutch bowel cancer screening population. METHODS AND RESULTS: Histological slides of adenomas with high-grade dysplasia and early colorectal carcinomas (CRC) from 20 different laboratories were reviewed by the pathology panel of the Dutch bowel screening programme. Interobserver variability was reported by descriptive statistics. In addition, potential clinical consequences of discrepancies were evaluated. A total of 104 cases of adenomas with high-grade dysplasia and 83 early CRCs were reviewed. Discrepancies were observed in 41 of 104 (39.4%) adenoma cases, which potentially had clinical consequences in 16 (15.4%) cases. For CRC, discrepancies were shown in 44 of 83 cases (53.0%) and would have potentially led to alternative treatment strategies in 25 (30.1%) cases. Most frequently, discrepancies were observed in the assessment of lymphovascular invasion (23 of 73 cases, 31.5%). CONCLUSION: This study showed that considerable interobserver variability is present in the histopathological assessment of advanced colorectal neoplasia, which may impact upon treatment choices. Additional stains and education, as well as intercollegial consultation, might decrease this variability.

Background The role of diverting ileostomy in total mesorectal excision (TME) for rectal cancer with primary anastomosis is debated. The aim of this study is to gain insight in the clinical consequences of a diverting ileostomy, with respect to stoma rate at one year and stoma-related morbidity. Methods Patients undergoing TME with primary anastomosis for rectal cancer between 2015 and 2017 in eleven participating hospitals were included. Retrospectively, two groups were compared: patients with or without diverting ileostomy construction during primary surgery. Primary endpoint was stoma rate at one year. Secondary endpoints were severity and rate of anastomotic leakage, overall morbidity rate within thirty days and stoma (reversal) related morbidity. Results In 353 out of 595 patients (59.3%) a diverting ileostomy was constructed during primary surgery. Stoma rate at one year was 9.9% in the non-ileostomy group and 18.7% in the ileostomy group (p = 0.003). After correction for confounders, multivariate analysis showed that the construction of a diverting ileostomy during primary surgery was an independent risk factor for stoma at one year (OR 2.563 (95%CI 1.424–4.611), p = 0.002). Anastomotic leakage rate was 17.8% in the non-ileostomy group and 17.2% in the ileostomy group (p = 0.913). Overall 30-days morbidity rate was 37.6% in the non-ileostomy group and 56.1% in the ileostomy group (p Conclusions The stoma rate at one year was higher in patients with ileostomy construction during primary surgery. The incidence and severity of anastomotic leakage were not reduced by construction of an ileostomy. The morbidity related to the presence and reversal of a diverting ileostomy was substantial.

Penile inversion vaginoplasty is the surgical gold standard for genital gender-affirming surgery in transgender women. When there is shortage of penile skin, because of previous circumcision, use of puberty blockers, biological variation, genital (self-)mutilation or when previous vaginoplasty has failed, a pedicled intestinal segment may be used as neovaginal lining. In this article, our surgical technique is presented, as well as surgical and patient-reported outcomes. Generally, postoperative outcomes are reported to be good. Surgical alternatives comprise full- or partial-thickness skin graft vaginoplasty, pedicled flap vaginoplasty, or peritoneal vaginoplasty.

Introduction: In early rectal cancer, organ sparing treatment strategies such as local excision have gained popularity. The necessity of radical surgery is based on the histopathological evaluation of the local excision specimen. This study aimed to describe diagnostic variability between pathologists, and its impact on treatment allocation in patients with locally excised early rectal cancer. Materials and methods: Patients with locally excised pT1-2 rectal cancer were included in this prospective cohort study. Both quantitative measures and histopathological risk factors (i.e. poor differentiation, deep submucosal invasion, and lymphatic- or venous invasion) were evaluated. Interobserver variability was reported by both percentages and Fleiss’ Kappa- (ĸ) or intra-class correlation coefficients. Results: A total of 126 patients were included. Ninety-four percent of the original histopathological reports contained all required parameters. In 73 of the 126 (57.9%) patients, at least one discordant parameter was observed, which regarded histopathological risk factors for lymph node metastases in 36 patients (28.6%). Interobserver agreement among different variables varied between 74% and 95% or ĸ 0.530–0.962. The assessment of lymphovascular invasion showed discordances in 26% (ĸ = 0.530, 95% CI 0.375–0.684) of the cases. In fourteen (11%) patients, discordances led to a change in treatment strategy. Conclusion: This study demonstrated that there is substantial interobserver variability between pathologists, especially in the assessment of lymphovascular invasion. Pathologists play a key role in treatment allocation after local excision of early rectal cancer, therefore interobserver variability needs to be reduced to decrease the number of patients that are over- or undertreated.

BACKGROUND: Transanal and robotic-assisted total mesorectal excision are techniques that can potentially overcome challenges encountered with a pure laparoscopic approach in patients with rectal cancer. OBJECTIVE: The aim of this study was to evaluate the proportion and predictive factors of restorative procedures and subsequent short-term outcomes of 3 minimally invasive techniques to treat low rectal cancer. DESIGN: This is a nationwide observational comparative registry study. SETTINGS: Patients with rectal cancer were selected from the mandatory Dutch ColoRectal Audit. PATIENTS: Patients with low rectal cancer (≤5 cm) who underwent curative minimally invasive total mesorectal excision between 2015 and 2018 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the proportion of restorative procedure, positive circumferential resection margin, and postoperative complications. RESULTS: A total of 3466 patients were included for analysis, of which 33% underwent a restorative procedure. Resections were performed laparoscopically in 2845 patients, transanally in 448 patients, and were robot-assisted in 173 patients, with a proportion of restorative procedures of 28%, 66%, and 40%. The transanal approach was independently associated with a restorative procedure (OR, 4.11; 95% CI, 3.21-5.26; p < 0.001). Independent risk factors for a nonrestorative procedure, irrespective of the surgical technique, were age >75 years, ASA physical status ≥3, BMI >30, history of abdominal surgery, clinical T4-stage, mesorectal fascia ≤1 mm, neoadjuvant therapy, and having a procedure in 2015 to 2016 versus 2017 to 2018. The circumferential resection margin involvement was similar for all 3 groups (5.4%, 5.1%, and 5.1%). Short-term postoperative complications were less favorable for the newer techniques than for the laparoscopic approach. LIMITATIONS: This study was limited because of the registry's variables and different group sizes. CONCLUSION: Patients with low rectal cancer in the Netherlands are more likely to receive a restorative procedure with a transanal approach, compared with a laparoscopic or robotic procedure. Short-term oncological outcomes are comparable between the 3 minimally invasive techniques. See Video Abstract at http://links.lww.com/DCR/B608. INFLUENCIA DE LA TCNICA DE RESECCIN MINIMAMENTE INVASIVA CON PRESERVACIN DE ESFNTERES EN LA RESOLUCIN A CORTO PLAZO EN CANCER DE TERCIO INFERIOR DE RECTO EN LOS PASES BAJOS: ANTECEDENTES:La excisión mesorrectal transanal y asistida por robot son técnicas que potencialmente pueden superar algunos obstáculos que podemos encontrar en un abordaje exclusivamente laparoscópico en pacientes con cáncer de recto.OBJECTIVOS:El objetivo de este estudio es evaluar la proporción y los factores de predicción positivos de los procedimientos restauradores y los resultados subsecuentes a corto plazo de tres técnicas mínimamente invasivas para tratar el cáncer de tercio inferior de recto.DISEÑO:Es un estudio comparativo observacional del registro nacional.ESCENARIO:Pacientes con cáncer de recto seleccionados del Registro Oficial de la Auditoría Holandesa Colo-rectal.PACIENTGES:Pacientes con cáncer de tercio inferior de recto (≤5 centimetros) sometidos a excision mesorrectal total mínimamente invasiva curativa.PRINCIPALES PARAMETROS DE EFECTIVIDAD:Proporción de procedimientos restauradores, margen de resección circunferencial positivo y complicaciones postoperatorias.RESULTADOS:Se incluyeron un total de 3,466 pacientes para análisis, de los cuales 33% fueron sometidos a procedimiento restaurador. Las resecciones fueron laparoscópica en 2,845 pacientes, transanal en 448 y asistidas por robot en 173, con una proporción de procedimientos restauradores en 28%, 66% y 40% respectivamente. El abordaje transanal se correlacionó en forma independiente con el procedimiento restaurador (OR 4.11; 95% CI 4.11; 95% CI 3.21-5.26; p75, American Society of Anesthesiologist ≥3, índice de masa corporal >30, antecedente de cirugía abdominal, Estadio clínico T4, fascia mesorrectal ≤1 millimetro, terapia neoadyuvante y haber sido sometido al procedimiento en 2015-2016 y no en 2017-2018. El margen circunferencial de resección involucrado fue similar para los tres grupos (5.4%, 5.1% y 5.1%). Las complicaciones postquirúrgicas a corto plazo fueron menos favorables para las técnicas nuevas comparadas con el abordaje laparoscópico.LIMTANTES:El estudio tiene la limitación de las variables dependientes del registro y la diferencia entre el número de pacientes en cada grupo.CONCLUSION:Los pacientes con cáncer de tercio inferior de recto en Holanda se tratan con mayor frecuencia mediante un procedimiento restaurador transanal en comparación con los abordajes laparoscópico o robótico. Los resultados favorables desde el punto de vista oncológico a corto plazo son comparables entre las tres técnicas de invasión mínima. Consulte Video Resumenhttp://links.lww.com/DCR/B608.

Background Almost half of all colorectal cancer (CRC) patients will experience metastases at some point, and in the majority of cases, multiple organs will be involved. If the peritoneum is involved in addition to the liver, the current guideline-driven treatment options are limited. The reported overall survival ranges from 6 to 13 months for the current standard of care (systemic treatment). This study aimed to evaluate morbidity and clinical long-term outcomes from a combined local treatment of hepatic metastases with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) used to treat peritoneal metastases. Methods A systematic search was performed in PubMed, Embase.com, Web of Science, and Cochrane. Studies evaluating the clinicopathologic data of patients who had both peritoneal and hepatic metastases treated with CRS-HIPEC were included provided sufficient data on the primary outcomes (overall and disease-free survival) were presented. The quality of included studies was assessed using the Methodological Index for Non-Randomized Studies (MINORS). Results Patients treated for peritoneal and liver metastases (PMLM group) had a pooled mean survival of 26.4 months (95% confidence interval [CI] 22.4–30.4 months), with a 3-year survival rate of 34% (95% CI 26.7–42.0%) and a 5-year survival rate of 25% (95% CI 17.3–33.8%). Surgical complications occurred more frequently for these patients than for those with peritoneal metastasis only (40% vs 22%; p = 0.0014), but the mortality and reoperation rates did not differ significantly. Conclusion This systematic review showed that CRS and HIPEC combined with local treatment of limited liver metastasis for selected patients is feasible, although with increased morbidity and an association with a long-term survival rate of 25%, which is unlikely to be achievable with systemic treatment only.

Contains fulltext : 238268.pdf (Publisher’s version ) (Closed access) IMPORTANCE: To date, no randomized clinical trials have investigated perioperative systemic therapy relative to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) alone for resectable colorectal peritoneal metastases (CPM). OBJECTIVE: To assess the feasibility and safety of perioperative systemic therapy in patients with resectable CPM and the response of CPM to neoadjuvant treatment. DESIGN, SETTING, AND PARTICIPANTS: An open-label, parallel-group phase 2 randomized clinical trial in all 9 Dutch tertiary centers for the surgical treatment of CPM enrolled participants between June 15, 2017, and January 9, 2019. Participants were patients with pathologically proven isolated resectable CPM who did not receive systemic therapy within 6 months before enrollment. INTERVENTIONS: Randomization to perioperative systemic therapy or CRS-HIPEC alone. Perioperative systemic therapy comprised either four 3-week neoadjuvant and adjuvant cycles of CAPOX (capecitabine and oxaliplatin), six 2-week neoadjuvant and adjuvant cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin), or six 2-week neoadjuvant cycles of FOLFIRI (fluorouracil, leucovorin, and irinotecan) and either four 3-week adjuvant cycles of capecitabine or six 2-week adjuvant cycles of fluorouracil with leucovorin. Bevacizumab was added to the first 3 (CAPOX) or 4 (FOLFOX/FOLFIRI) neoadjuvant cycles. MAIN OUTCOMES AND MEASURES: Proportions of macroscopic complete CRS-HIPEC and Clavien-Dindo grade 3 or higher postoperative morbidity. Key secondary outcomes were centrally assessed rates of objective radiologic and major pathologic response of CPM to neoadjuvant treatment. Analyses were done modified intention-to-treat in patients starting neoadjuvant treatment (experimental arm) or undergoing upfront surgery (control arm). RESULTS: In 79 patients included in the analysis (43 [54%] men; mean [SD] age, 62 [10] years), experimental (n = 37) and control (n = 42) arms did not differ significantly regarding the proportions of macroscopic complete CRS-HIPEC (33 of 37 [89%] vs 36 of 42 [86%] patients; risk ratio, 1.04; 95% CI, 0.88-1.23; P = .74) and Clavien-Dindo grade 3 or higher postoperative morbidity (8 of 37 [22%] vs 14 of 42 [33%] patients; risk ratio, 0.65; 95% CI, 0.31-1.37; P = .25). No treatment-related deaths occurred. Objective radiologic and major pathologic response rates of CPM to neoadjuvant treatment were 28% (9 of 32 evaluable patients) and 38% (13 of 34 evaluable patients), respectively. CONCLUSIONS AND RELEVANCE: In this randomized phase 2 trial in patients diagnosed with resectable CPM, perioperative systemic therapy seemed feasible, safe, and able to induce response of CPM, justifying a phase 3 trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02758951.

Aim Transanal total mesorectal excision (TaTME) has been suggested as a potential solution for the resection of challenging mid and low rectal cancer. This relatively complex procedure has been implemented in many centres over the last years, despite the absence of long‐term safety data. Recently, concern has arisen because of an increase in local recurrence in the implementation phase. The aim of this study was to assess the correlation between accumulated experience and local recurrences. Method An independent clinical researcher performed an external audit of consecutive series of all TaTME procedures in six centres in the Netherlands. Kaplan–Meier estimated local recurrence rates were calculated and multivariate Cox proportional hazards regression analysis performed to assess risk factors for local recurrence. Primary outcome was the local recurrence rate in the initial implementation (cases 1–10), continued adoption (cases 11‐40) and prolonged experience (case 41 onward). Results Six hundred and twenty‐four consecutive patients underwent TaTME for rectal cancer with a median follow‐up of 27 months (range 1–82 months). The estimated 2‐ and 3‐year local recurrence rates were 4.6% and 6.6%, respectively. Cox proportional hazards regression revealed procedural experience to be an independent factor in multivariate analysis next to advanced stage (ycMRF+, pT3‐4, pN+) and pelvic sepsis. Corrected analysis projected the 3‐year local recurrence rates to be 9.7%, 3.3% and 3.5% for the implementation, continued adoption and prolonged experience cohorts, respectively. Conclusion This multicentre study shows a high local recurrence rate (12.5%) after implementation of TaTME which lowers to an acceptable rate (3.4%) when experience increases. Therefore, intensified proctoring and further precautions must be implemented to reduce the unacceptably high risk of local recurrence at units starting this technique.

Background Machine learning (ML) has been introduced in various fields of healthcare. In colorectal surgery, the role of ML has yet to be reported. In this systematic review, an overview of machine learning models predicting surgical outcomes after colorectal surgery is provided. Methods Databases PubMed, EMBASE, Cochrane, and Web of Science were searched for studies using machine learning models for patients undergoing colorectal surgery. To be eligible for inclusion, studies needed to apply machine learning models for patients undergoing colorectal surgery. Absence of machine learning or colorectal surgery or studies reporting on reviews, children, study abstracts were excluded. The Probast risk of bias tool was used to evaluate the methodological quality of machine learning models. Results A total of 1821 studies were analysed, resulting in the inclusion of 31 articles. A vast proportion of ML algorithms have been used to predict the course of disease and response to neoadjuvant chemoradiotherapy. Radiomics have been applied most frequently, along with predictive accuracies up to 91%. However, most studies included a retrospective study design without external validation or calibration. Conclusions Machine learning models have shown promising potential in predicting surgical outcomes after colorectal surgery. However, large-scale data is warranted to bridge the gap between calibration and external validation. Clinical implementation is needed to demonstrate the contribution of ML within daily practice.

Background: The treatment of locally advanced or recurrent anorectal cancer requires radical surgery such as extralevator abdominoperineal resection and pelvic exenteration. Larger defects require flap reconstruction. The authors evaluated outcomes of different perineal reconstruction techniques. Methods: A systematic search was performed in the PubMed, Embase, and Cochrane databases. Studies reporting outcomes on perineal flap reconstruction in patients with anal or colorectal cancer were included. Data on patient characteristics, surgical details, perineal and donor-site complications, revision surgery, mortality, and quality of life were extracted. Articles were assessed using the Group Reading Assessment and Diagnostic Evaluation approach. Results: The authors included 58 mainly observational studies comprising 1988 patients. Seventy-three percent of patients had rectal cancer. The majority of 910 abdominoperineal resection patients underwent reconstruction with rectus abdominis flaps (91 percent). Dehiscence (15 to 32 percent) and wound infection (8 to 16 percent) were the most common complications. Partial flap necrosis occurred in 2 to 4 percent and flap loss occurred in 0 to 2 percent. Perineal herniation was seen in 6 percent after gluteal flap reconstruction and in 0 to 1 percent after other types of reconstruction. Donor-site complications were substantial but were reported inconsistently. Conclusions: Clinical outcome data on perineal reconstruction after exenterative surgery are mostly of very low quality. Perineal reconstruction after pelvic exenteration is complex and requires a patient-tailored approach. Primary defect size, reconstruction aims, donor-site availability, and long-term morbidity should be taken into account. This review describes the clinical outcomes of four flap reconstruction techniques. Shared clinical decision-making on perineal reconstruction should be based on these present comprehensive data.

Background In patients with rectal cancer, enlarged lateral lymph nodes (LLNs) result in increased lateral local recurrence (LLR) and lower cancer-specific survival (CSS) rates, which can be improved with (chemo)radiotherapy ((C)RT) and LLN dissection (LLND). This study investigated whether different LLN locations affect oncological outcomes. Methods Patients with low cT3–4 rectal cancer without synchronous distant metastases were included in this multicentre retrospective cohort study. All MRI was re-evaluated, with special attention to LLN involvement and response. Results More advanced cT and cN category were associated with the occurrence of enlarged obturator nodes. Multivariable analyses showed that a node in the internal iliac compartment with a short-axis (SA) size of at least 7 mm on baseline MRI and over 4 mm after (C)RT was predictive of LLR, compared with a post-(C)RT SA of 4 mm or less (hazard ratio (HR) 5.74, 95 per cent c.i. 2.98 to 11.05 vs HR 1.40, 0.19 to 10.20; P Conclusion Internal iliac LLN enlargement is associated with an increased LLR rate, whereas obturator nodes are associated with more advanced disease with increased distant metastasis and reduced CSS rates. LLND improves local control in persistent internal iliac nodes, and might have a role in controlling systemic spread in persistent obturator nodes. Members of the Lateral Node Study Consortium are co-authors of this study and are listed under the heading Collaborators.

Background Adequate MRI‐based staging of early rectal cancers is essential for decision‐making in an era of organ‐conserving treatment approaches. The aim of this population‐based study was to determine the accuracy of routine daily MRI staging of early rectal cancer, whether or not combined with endorectal ultrasonography (ERUS). Methods Patients with cT1–2 rectal cancer who underwent local excision or total mesorectal excision (TME) without downsizing (chemo)radiotherapy between 1 January 2011 and 31 December 2018 were selected from the Dutch ColoRectal Audit. The accuracy of imaging was expressed as sensitivity, specificity, and positive predictive value (PPV) and negative predictive value. Results Of 7382 registered patients with cT1–2 rectal cancer, 5539 were included (5288 MRI alone, 251 MRI and ERUS; 1059 cT1 and 4480 cT2). Among patients with pT1 tumours, 54·7 per cent (792 of 1448) were overstaged by MRI alone, and 31·0 per cent (36 of 116) by MRI and ERUS. Understaging of pT2 disease occurred in 8·2 per cent (197 of 2388) and 27·9 per cent (31 of 111) respectively. MRI alone overstaged pN0 in 17·3 per cent (570 of 3303) and the PPV for assignment of cN0 category was 76·3 per cent (2733 of 3583). Of 834 patients with pT1 N0 disease, potentially suitable for local excision, tumours in 253 patients (30·3 per cent) were staged correctly as cT1 N0, whereas 484 (58·0 per cent) and 97 (11·6 per cent) were overstaged as cT2 N0 and cT1–2 N1 respectively. Conclusion This Dutch population‐based analysis of patients who underwent local excision or TME surgery for cT1–2 rectal cancer based on preoperative MRI staging revealed substantial overstaging, indicating the weaknesses of MRI and missed opportunities for organ preservation strategies., This population‐based study determined the accuracy of routine daily MRI staging of early rectal cancer, whether or not combined with endorectal ultrasonography. The results showed that preoperative MRI led to substantial overstaging in patients who underwent local excision or total mesorectal incision surgery for cT1–2 rectal cancer, indicating the weaknesses of MRI and missed opportunities for organ preservation strategies. Imaging weakness

Background Abdominoperineal excision (APE) for rectal cancer is associated with a relatively high risk of positive margins and postoperative morbidity, particularly related to perineal wound healing problems. It is unknown whether the use of a minimally invasive approach for the perineal part of these procedures can improve postoperative outcomes without oncological compromise. The aim of this study was to evaluate the feasibility of minimally invasive transperineal abdominoperineal excision (TpAPE) Methods This multicenter retrospective cohort study included all patients having TpAPE for primary low rectal cancer. The primary endpoint was the intraoperative complication rate. Secondary endpoints included major morbidity (Clavien–Dindo ≥ 3), histopathology results, and perineal wound healing. Results A total of 32 TpAPE procedures were performed in five centers. A bilateral extralevator APE (ELAPE) was performed in 17 patients (53%), a unilateral ELAPE in 7 (22%), and an APE in 8 (25%). Intraoperative complications occurred in five cases (16%) and severe postoperative morbidity in three cases (9%). There were no perioperative deaths. A positive margin (R1) was observed in four patients (13%) and specimen perforation occurred in two (6%). The unilateral extralevator TpAPE group had worse specimen quality and a higher proportion of R1 resections than the bilateral ELAPE or standard APE groups. The rate of uncomplicated perineal wound healing was 53% (n = 17) and three patients (9%) required surgical reintervention. Conclusions TpAPE seems to be feasible with acceptable perioperative morbidity and a relatively low rate of perineal wound dehiscence, while histopathological outcomes remain suboptimal. Additional evaluation of the viability of this technique is needed in the form of a prospective trial with standardization of the procedure, indication, audit of outcomes and performed by surgeons with vast experience in transanal total mesorectal excision.

Background Transanal total mesorectal excision (TaTME) has been proposed as an approach in patients with mid and low rectal cancer. The TaTME procedure has been introduced in the Netherlands in a structured training pathway, including proctoring. This study evaluated the local recurrence rate during the implementation phase of TaTME. Methods Oncological outcomes of the first ten TaTME procedures in each of 12 participating centres were collected as part of an external audit of procedure implementation. Data collected from a cohort of patients treated over a prolonged period in four centres were also collected to analyse learning curve effects. The primary outcome was the presence of locoregional recurrence. Results The implementation cohort of 120 patients had a median follow up of 21·9 months. Short‐term outcomes included a positive circumferential resection margin rate of 5·0 per cent and anastomotic leakage rate of 17 per cent. The overall local recurrence rate in the implementation cohort was 10·0 per cent (12 of 120), with a mean(s.d.) interval to recurrence of 15·2(7·0) months. Multifocal local recurrence was present in eight of 12 patients. In the prolonged cohort (266 patients), the overall recurrence rate was 5·6 per cent (4·0 per cent after excluding the first 10 procedures at each centre). Conclusion TaTME was associated with a multifocal local recurrence rate that may be related to suboptimal execution rather than the technique itself. Prolonged proctoring, optimization of the technique to avoid spillage, and quality control is recommended., During the learning curve, the transanal total mesorectal excision procedure is associated with a high multifocal local recurrence rate, which appears to be related to suboptimal execution rather than the technique, and necessitates prolonged proctoring, optimization of the technique avoiding spillage, participation in controlled clinical trials with surgical quality control, and centralization until oncological safety is demonstrated. Defines a learning curve

Aim To provide dynamic guidance from a rigorous and up-to-date consensus on the safe implementation and application of transanal total mesorectal excision (TaTME) from an international panel of expert surgeons and educationalists supported by 14 international surgical societies. Method An adapted Delphi method and focus group discussion approach was implemented for this consensus process, with expert advice from a guidelines methodologist. Statements were generated focusing on three main topics relating to the safe implementation of TaTME: (1) indications, (2) quality and outcome measures, (3) training and implementation of TaTME. Results Five rounds of the Delphi consensus process were completed over a 13-month period. A total of 56 surgeons experienced in TaTME and surgical education participated in this project. By Delphi round four, 80.0% or greater agreement was reached for all statements except for two, which were further reviewed during a fifth round. More complex cases that are likely to benefit from TaTME were identified, with the recommendation that they should be referred to TaTME expert centres. The most agreed upon definition of expert centres is outlined. Conclusion We have provided a current framework of best practice related to implementation of TaTME. The statements are not indefinite and will continue to be 'dynamic' and updated as new evidence emerges.

Background: Anastomotic leakage (AL) remains a severe complication following colorectal surgery, having a negative impact on both short- and long-term outcomes. Since timely detection could enable early intervention, there is a need for the development of novel and accurate, preferably, non-invasive markers. The aim of this study was to investigate whether urinary intestinal fatty acid binding protein (I-FABP) could serve as such a marker. Methods: This prospective multicenter cross-sectional phase two diagnostic study was conducted at four centers in the Netherlands between March 2015 and November 2016. Urine samples of 15 patients with confirmed colorectal AL and 19 patients without colorectal AL on postoperative day 3 were included. Urinary I-FABP levels were determined using enzyme-linked immunosorbent assays and adjusted for urinary creatinine to compensate for renal dysfunction. Results: Urinary I-FABP levels were significantly elevated in patients with confirmed AL compared to patients without AL on postoperative day 3 (median: 2.570 ng/ml vs 0.809 ng/ml, p = 0.006). The area under the receiver operating characteristics curve (AUROC) was 0.775, yielding a sensitivity of 80% and specificity of 74% at the optimal cutoff point (> 1.589 ng/ml). This difference remained significant after calculation of I-FABP/creatinine ratios (median: 0.564 ng/µmol vs. 0.158 ng/µmol, p = 0.040), with an AUROC of 0.709, sensitivity of 60% and specificity of 90% at the optimal cutoff point (> 0.469 ng/µmol). Conclusions: Levels of urinary I-FABP and urinary I-FABP/creatinine were significantly elevated in patients with confirmed AL following colorectal surgery, suggesting their potential as a non-invasive biomarker for colorectal anastomotic leakage.

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., A novel surgical technique for total mesorectal excision (TME) is single‐port transanal minimally invasive surgery. This systematic review aimed to evaluate the functional outcomes and quality of life after transanal total mesorectal excision (TaTME) and compare them with those of laparoscopic TME (LapTME). No differences between TaTME and LapTME were seen in terms of impaired functioning and reduced quality of life after rectal cancer surgery. However, major heterogeneity was present in the studies together with poor reporting of functional baseline assessment. Comparable function

Introduction: The aim was assess the oncological and functional outcome of the watch-and-wait (W&W) approach in older patients with a clinical (near)complete response after neoadjuvant treatment for rectal cancer.Material and methods: Patients were included in a W&W-approach (2004-2019) when digital rectal examination, endoscopy and MRI showed a (near)clinical complete response. Patients underwent endoscopy and MRI every 3 months during the first year, and 6-monthly thereafter. Patients aged >= 75 and >= 2 years of follow-up (FU) were selected. Oncological outcomes were assessed with Kaplan-Meier curves. Functional outcome was assessed with colostomy-free rate, Vaizey incontinence score, low anterior resection syndrome-score and International Prostate Syndrome Score.Results: 43/304 (14%) of patients in a W&W-approach met the inclusion criteria. Median FU was 37 (24-109) months. 5/43(12%) developed a local regrowth. All were treated surgically, with one patient experiencing a pelvic failure. Distant metastases occurred in 3/43 patients and 4 patients died, 3 of whom not related to rectal cancer. The 3-year local regrowth-free rate was 88%, 3-year non-regrowth disease-free survival 91%, overall survival 97% and 3-year colostomy-free rate 93%. Overall, the bowel- and urinary dysfunction scores at 3, 12 and 24 months indicated good continence, no or minor LARS and moderate urinary problems.Conclusion: W&W for older patients with a clinical (near) complete response appears to be a safe alternative to a total mesorectal excision (TME), with a very high pelvic control rate, and few rectal cancer related deaths. Most patients can avoid major surgery and a definitive colostomy, and have a reasonable anorectal and urinary function. (C) 2020 Elsevier Ltd, BASO similar to The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Highlights • Iatrogenic recto-urogenital fistulae rarely heal without surgical treatment. • The major challenge in pelvic redo surgery is to achieve adequate exposure. • A minimally invasive perineal approach using a SILS port seems a good treatment., Introduction Iatrogenic recto-urogenital fistulae are refractory complications that rarely heal without surgical intervention. The ongoing local infection causes pain, discomfort and substantially impacts quality of life. Surgical repair requires adequate exposure and space to fill with healthy tissue, which is a major challenge in pelvic redo surgery. An abdominal approach to repair the fistula is associated with major morbidity and often fails to expose the deep pelvis. In our experience a novel transperineal minimally invasive approach a utilizing single incision laparoscopic surgery (SILS) technique could offer improved results. Presentation of cases In the present study, three cases of patients with recto-urogenital fistulae after pelvic surgery are described. Two patients were diagnosed with a rectovesical fistula and one patient with a rectovaginal fistula. In all three cases, a minimally invasive perineal approach, using a SILS port, was used to perform surgical repair. The closure of the fistulae involved: a separate repair of the urethra/bladder or vaginal defect and the rectal defect, followed by interposition of vascularized tissue by either a pudendal thigh fasciocutaneous flap or omentoplasty. Discussion and conclusion This study is the first to report on a minimally invasive perineal approach, utilizing a SILS technique for recto-urogenital fistulae repair after previous pelvic surgery. The current approach improves exposure, creates surgical space, optimizes view and allows the interposition of vascularized tissue, without causing substantial blood loss and avoiding major abdominal surgery.

The role of diverting ileostomy in total mesorectal excision (TME) for rectal cancer with primary anastomosis is debated. The aim of this study is to gain insight in the clinical consequences of a diverting ileostomy, with respect to stoma rate at one year and stoma-related morbidity.Patients undergoing TME with primary anastomosis for rectal cancer between 2015 and 2017 in eleven participating hospitals were included. Retrospectively, two groups were compared: patients with or without diverting ileostomy construction during primary surgery. Primary endpoint was stoma rate at one year. Secondary endpoints were severity and rate of anastomotic leakage, overall morbidity rate within thirty days and stoma (reversal) related morbidity.In 353 out of 595 patients (59.3%) a diverting ileostomy was constructed during primary surgery. Stoma rate at one year was 9.9% in the non-ileostomy group and 18.7% in the ileostomy group (p = 0.003). After correction for confounders, multivariate analysis showed that the construction of a diverting ileostomy during primary surgery was an independent risk factor for stoma at one year (OR 2.563 (95%CI 1.424-4.611), p = 0.002). Anastomotic leakage rate was 17.8% in the non-ileostomy group and 17.2% in the ileostomy group (p = 0.913). Overall 30-days morbidity rate was 37.6% in the non-ileostomy group and 56.1% in the ileostomy group (p 0.001). Stoma reversal related morbidity rate was 17.9%.The stoma rate at one year was higher in patients with ileostomy construction during primary surgery. The incidence and severity of anastomotic leakage were not reduced by construction of an ileostomy. The morbidity related to the presence and reversal of a diverting ileostomy was substantial.

Background This study aimed to assess the impact of open or laparoscopic resection of primary colorectal cancer (CRC) on the development of metachronous colorectal peritoneal metastases (CPM) in a population-based cohort. Materials and methods This was a retrospective, population-based study of CRC patients who underwent open or laparoscopic resection of the primary tumour in the Netherlands between January 1st and June 30th 2015. Patients with synchronous metastases were excluded. CPM were considered metachronous if diagnosed ≥ 90 days after resection of primary CRC. Multivariable cox regression analysis was performed to correct for tumour location, histology, differentiation, and stage, nodal stage, tumour perforation, primary surgery type, and unclear resection margins. Results In total, 1516 CRC patients underwent open resection and 3236 CRC patients underwent laparoscopic resection, with a 3-year cumulative incidence of metachronous CPM of 7.3% and 3.7%, respectively (p Conclusions Patients treated with open resection had a significantly higher risk to develop metachronous CPM than patients treated with laparoscopic resection. The mechanisms underlying this phenomenon remain unknown but might be related to differences in per-operative specimen handling, tumour spill, surgical trauma and pro-inflammatory response. This finding might imply the need for a personalized follow-up after primary resection of CRC.

Colorectal cancer (CRC) is the second leading cause for cancer-related death globally. Clinically, there is an urgent need for non-invasive CRC detection. This study assessed the feasibility of CRC detection by analysis of tumor-derived methylated DNA fragments in urine. Urine samples, including both unfractioned and supernatant urine fractions, of 92 CRC patients and 63 healthy volunteers were analyzed for DNA methylation levels of 6 CRC-associated markers (SEPT9, TMEFF2, SDC2, NDRG4, VIM and ALX4). Optimal marker panels were determined by two statistical approaches. Methylation levels of SEPT9 were significantly increased in urine supernatant of CRC patients compared to controls (p SEPT9 and SDC2 was able to detect up to 70% of CRC cases in urine supernatant at 86% specificity. First evidence is provided for CRC detection in urine by SEPT9 methylation analysis, which combined with SDC2 allows for an optimal differentiation between CRC patients and controls. Urine therefore provides a promising liquid biopsy for non-invasive CRC detection.