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This study aimed to quantify the confirmation of gallstones on ultrasound (US) in patients with suspicion of gallstone disease. To aid general practitioners (GPs) in diagnostic workup, a model to predict gallstones was developed. A prospective cohort study was conducted in two Dutch general hospitals. Patients (≥18 years) were eligible for inclusion when referred by GPs for US with suspicion of gallstones. The primary outcome was the confirmation of gallstones on US. A multivariable regression model was developed to predict the presence of gallstones. In total, 177 patients were referred with a clinical suspicion of gallstones. Gallstones were found in 64 of 177 patients (36.2%). Patients with gallstones reported higher pain scores (VAS 8.0 vs. 6.0, p < 0.001), less frequent pain (21.9% vs. 54.9%, p < 0.001), and more often met criteria for biliary colic (62.5% vs. 44.2%, p = 0.023). Predictors for the presence of gallstones were a higher pain score, frequency of pain less than weekly, biliary colic, and an absence of heartburn. The model showed good discrimination between patients with and without gallstones (C-statistic 0.73, range: 0.68–0.76). Clinical diagnosis of symptomatic gallstone disease is challenging. The model developed in this study may aid in the selection of patients for referral and improve treatment related outcomes.

Contains fulltext : 290664.pdf (Publisher’s version ) (Open Access) Introduction: The aim of this study was to review the effect of irreversible electroporation parameter settings on the size of the ablation zone and the occurrence of thermal effects. This insight would help to optimize treatment protocols and effectively ablate a tumor while controlling the occurrence of thermal effects. Methods: Various individual studies report the influence of variation in electroporation parameters on the ablation zone size or occurrence of thermal effects. However, no connections have yet been established between these studies. With the aim of closing the gap in the understanding of and personalizing irreversible electroporation parameter settings, a systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A quality assessment was performed using an in-house developed grading tool based on components of commonly used grading domains. Data on the electroporation parameters voltage, number of electrodes, inter-electrode distance, active needle length, pulse length/number/protocol/frequency, and pulse interval were extracted. Ablation zone size and temperature data were grouped per parameter. Spearman correlation and linear regression were used to define the correlation with outcome measures. Results: A total of 7661 articles were screened, of which 18 preclinical studies (animal and phantom studies) met the inclusion criteria. These studies were graded as moderate (4/18) and low (14/18) quality. Only the applied voltage appeared to be a significant linear predictor of ablation zone size: length, surface, and volume. The pulse number was moderately but nonlinearly correlated with the ablation zone length. Thermal effects were more likely to occur for higher voltages (≥2000 V), higher number of electrodes, and increased active needle length. Conclusion: Firm conclusions are limited since studies that investigated and precisely reported the influence of electroporation parameters on the ablation zone size and thermal effects were scarce and mostly graded low quality. High-quality studies are needed to improve the predictability of the combined effect of variation in parameter combinations and optimize irreversible electroporation treatment protocols.

Contains fulltext : 232906.pdf (Publisher’s version ) (Open Access) BACKGROUND: Preoperative differentiation between neoplastic and nonneoplastic gallbladder polyps, and the subsequent indication for cholecystectomy remains a clinical dilemma. The current 1 cm size threshold for neoplasia is unspecific. The aim of this study was to improve diagnostic work-up for gallbladder polyps using sonographic and MRI characteristics of neoplastic and nonneoplastic polyps. METHODS: A prospective, exploratory study including patients undergoing cholecystectomy for gallbladder polyp(s) was conducted. Patients underwent targeted transabdominal ultrasound (TAUS) and MRI. Outcomes were sensitivity and specificity for polyp diagnosis, and the radiological characteristics of neoplastic and nonneoplastic polyp types. Histopathology after cholecystectomy was used as reference standard. RESULTS: Histopathology demonstrated gallbladder polyps in 20/27 patients (74%): 14 cholesterol polyps, three adenomyomatosis, two adenomas and one gastric heterotopia. Sensitivity of polyp identification were 72% (routine TAUS) and 86% (targeted TAUS and MRI). Both adenomas were identified as neoplastic on targeted TAUS and MRI. Sonographic presentation as multiple, pedunculated polyps, either heterogeneous or with hyperechoic foci, or as single polyps containing cysts were limited to nonneoplastic polyps. On MRI hyperintense polyps on T1-weighted image were cholesterol polyps. An adenoma with high-grade dysplasia showed foci of decreased ADC values. We propose a checklist for polyp evaluation by targeted TAUS and a flowchart for radiological work-up of gallbladder polyps. CONCLUSIONS: The presented checklist and flowchart could aid diagnostic work-up for gallbladder polyps compared to current routine ultrasound, by elimination of nonneoplastic polyps and ultimately improve treatment decision for patients with gallbladder polyps.

Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) or biopsy (FNB) to diagnose lesions in the gastrointestinal tract is common. Demand for histology sampling to identify treatment-specific targets is increasing. Various core biopsy FNB needles to obtain tissue for histology are currently available, however, with variable (37–97%) histology yields. In this multicenter study, we evaluated performance, safety, and user experience of a novel device (the puncture biopsy forceps (PBF) needle). Twenty-four procedures with the PBF needle were performed in 24 patients with a suspected pancreatic lesion (n = 10), subepithelial lesion (n = 10), lymph node (n = 3), or pararectal mass (n = 1). In 20/24 (83%) procedures, the PBF needle yielded sufficient material for interpretation (sample adequacy). In 17/24 (71%), a correct diagnosis was made with the material from the PBF needle (diagnostic accuracy). All participating endoscopists experienced a learning curve. (Per)procedural technical issues occurred in four cases (17%), but there were no adverse events. The PBF needle is a safe and potentially useful device to obtain an EUS-guided biopsy specimen. As the design of the PBF needle is different to core biopsy FNB needles, specific training will likely further improve the performance of the PBF needle. Furthermore, the design of the needle needs further improvement to make it more robust in clinical practice.

Objectives: A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups. Methods: Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30). Results: Budget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%). Conclusion: Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones. Trial registration: The Netherlands National Trial Register NTR4022. Registered on June 5, 2013.

ObjectivesTo examine general practitioners’ (GP) management of cholecystolithiasis and to evaluate persisting abdominal complaints in the years after the diagnosis.DesignRetrospective analysis of registry data and a subset of individual medical records.SettingSeventeen primary care practices affiliated with the Radboudumc Practice Based Research Network in the Netherlands.Participants633 patients with cholecystolithiasis diagnosed between 2012 and 2016.Primary and secondary outcome measuresThe primary outcome of this study was the healthcare utilisation of patients with cholecystolithiasis diagnosed by the GP in terms of referrals to secondary care, laboratory diagnostics, prescribed medication and the prevalence of concomitant abdominal-related diagnoses in a time interval of 3 years before and 3 years after diagnosis of cholecystolithiasis. For secondary outcomes, electronic medical records were studied from seven practices to assess emergency department visits, operation rates and repeat visits for persistent abdominal symptoms. We compared the non-referred group with the referred group.ResultsIn 57% of patients, concomitant abdominal-related diagnoses were recorded besides the diagnosis cholecystolithiasis. In-depth analyses of 294 patients showed a referral rate of 79.3% (n=233); 62.9% (n=185) underwent cholecystectomy. After referral, 55.4% (129/233) returned to the GP for persistent abdominal symptoms. Patients returning after referral were more often treated for another abdominal-related diagnosis before cholecystolithiasis was recorded (51.9% vs 28.8%, pConclusionsThe majority of patients in general practice with gallstones are referred and undergo cholecystectomy. Patients with concomitant abdominal-related diagnoses are likely to return to their physician. GPs should inform patients about these outcomes to improve the shared decision-making process before gallbladder surgery.

Objective To perform a cost-effectiveness analysis (CEA) of restrictive strategy versus usual care in patients with gallstones and abdominal pain. Summary background data A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. Methods Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months. Results All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients was pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with O160 per patient, O162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved O4563 from a societal perspective per pain-free patient lost. Conclusions A restrictive selection strategy for cholecystectomy saves O162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of O4563 per pain-free patient lost. The higher societal willingness to pay for one extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. Trial registration The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.

Contains fulltext : 220016.pdf (Publisher’s version ) (Open Access) OBJECTIVES: Obesity is a risk factor for several phenotypes such as gallstones, metabolic syndrome (MS), and nonalcoholic fatty liver disease (NAFLD). It has been suggested that cholecystectomy is a risk factor for metabolic abnormalities and NAFLD. We aimed to determine whether cholecystectomy is associated with MS or NAFLD in a Dutch population-based study. METHODS: The Rotterdam Study is an ongoing prospective population-based cohort. We included participants who underwent a liver ultrasound between 2009 and 2014 to assess steatosis. The prevalence of MS and NAFLD was calculated, and we performed regression analyses relating cholecystectomy with MS and NAFLD and adjusted for age, sex, study cohort, education level, physical activity, energy intake, time since cholecystectomy, body mass index, presence of hypertension, diabetes mellitus, and steatosis/MS. RESULTS: We included 4,307 participants (57.5% women, median age 66.0 years [interquartile range 58-74]). In total, 265 participants (6.2%) underwent a cholecystectomy. The median age at the time of cholecystectomy was 57.0 years (47.5-66.5), and the median time from cholecystectomy to imaging of the liver was 10.0 years (0.5-19.5). The prevalence of MS in participants with cholecystectomy was 67.2% and 51.9% in participants without cholecystectomy (P < 0.001). Ultrasound diagnosed moderate/severe NAFLD was present in, respectively, 42.7% and 34.2% of the participants (P = 0.008). After multivariable adjustments for metabolic factors, cholecystectomy was no longer associated with the presence of MS or NAFLD. DISCUSSION: The prevalence of MS and NAFLD is higher in participants after cholecystectomy. However, our trial shows that cholecystectomy may not be independently associated with the presence of MS and NAFLD after correction for metabolic factors.

Background: A significant proportion of gallbladder polyps are non-neoplastic, for which resection is not necessary. However, international guidelines advocate cholecystectomy for all polyps ≥ 1 cm. This study assessed a national cohort of histopathologically proven gallbladder polyps to distinguish neoplastic from non-neoplastic polyps. Methods: PALGA, the nationwide network and registry of histo- and cytopathology, was searched to identify all histopathologically proven gallbladder polyps between 2003 and 2013. All polyps and (focal) wall thickenings > 5 mm were included, and classified as neoplastic or non-neoplastic. Polyp subtype, size, distribution, presentation as wall thickening or protruding polyp, and presence of gallstones were assessed for neoplastic and non-neoplastic polyps. A decision tree to distinguish neoplastic and non-neoplastic polyps was made and diagnostic accuracy of 1 cm surgical threshold was calculated. Results: A total of 2085 out of 220,612 cholecystectomies contained a polyp (0.9%). Of these polyps, 56.4% were neoplastic (40.1% premalignant, 59.9% malignant) and 43.6% non-neoplastic (41.5% cholesterol polyp, 37.0% adenomyomatosis, 21.5% other). Polyp size, distribution, and presence of gallstones were reported in 1059, 1739 and 1143 pathology reports, respectively. Neoplastic polyps differed from non-neoplastic polyps in size (18.1 mm vs 7.5 mm, p < 0.001), singularity (88.2% vs 68.2%, p < 0.001), wall thickening (29.1% vs 15.6%, p < 0.001), and presence of gallstones (50.1% vs 40.4%, p = 0.001). However, adenomyomatosis presented with similar characteristics as neoplastic polyps. Fifty percent of polyps were ≥ 1 cm surgical threshold (optimal surgical threshold based on ROC-curve); sensitivity for indicating neoplastic polyps was 68.1%, specificity was 70.2%, and positive and negative predictive values were 72.9% and 65.1%. Conclusions: The prevalence of gallbladder polyps on cholecystectomy is low and many of the polyps are non-neoplastic. Clinicopathological characteristics differ between neoplastic and non-neoplastic polyps in general, but these cannot properly indicate neoplasia. The 1 cm surgical threshold has moderate diagnostic accuracy and is insufficient to indicate surgery for neoplastic gallbladder polyps.

BACKGROUND & AIMS: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. METHODS: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (+/- 11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores. RESULTS: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups. CONCLUSIONS: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.

Gallbladder cancer (GBC) is rare in Western populations and data about treatment and outcomes are scarce. This study aims to analyze survival and identify opportunities for improvement using population-based data from a low-incidence country. GBC patients diagnosed between 2005 and 2016 with GBC were identified from the Netherlands Cancer Registry. Patients were grouped according to time period (2005–2009/2010–2016) and disease stage. Trends in treatment and overall survival (OS) were analyzed. In total 1834 patients were included: 661 (36%) patients with resected, 278 (15%) with non-resected non-metastatic, and 895 (49%) with metastatic GBC. Use of radical versus simple cholecystectomy (12% vs. 26%, p < 0.001) in early (pT1b/T2) GBC increased. More patients with metastatic GBC received chemotherapy (11% vs. 29%, p < 0.001). OS improved from 4.8 months (2005–2009) to 6.1 months (2010–2016) (p = 0.012). Median OS increased over time (2005–2009 vs. 2010–2016) in resected (19.4 to 26.8 months, p = 0.038) and metastatic (2.3 vs. 3.4 months, p = 0.001) GBC but not in unresected, non-metastatic GBC. In early GBC, patients with radical cholecystectomy had a median OS of 76.7 compared to 18.4 months for simple cholecystectomy (p < 0.001). Palliative chemotherapy showed superior (p < 0.001) survival in metastatic (7.3 versus 2.1 months) and non-resected non-metastatic (7.7 versus 3.5 months) GBC. In conclusion, survival of GBC remains poor. Radical surgery and palliative chemotherapy appear to improve prognosis but remain under-utilized.

OBJECTIVES: Large biobanks with uniform collection of biomaterials and associated clinical data are essential for translational research. The Netherlands has traditionally been well organized in multicenter clinical research on pancreatic diseases, including the nationwide multidisciplinary Dutch Pancreatic Cancer Group and Dutch Pancreatitis Study Group. To enable high-quality translational research on pancreatic and periampullary diseases, these groups established the Dutch Pancreas Biobank.METHODS: The Dutch Pancreas Biobank is part of the Parelsnoer Institute and involves all 8 Dutch university medical centers and 5 nonacademic hospitals. Adult patients undergoing pancreatic surgery (all indications) are eligible for inclusion. Preoperative blood samples, tumor tissue from resected specimens, pancreatic cyst fluid, and follow-up blood samples are collected. Clinical parameters are collected in conjunction with the mandatory Dutch Pancreatic Cancer Audit.RESULTS: Between January 2015 and May 2017, 488 patients were included in the first 5 participating centers: 4 university medical centers and 1 nonacademic hospital. Over 2500 samples were collected: 1308 preoperative blood samples, 864 tissue samples, and 366 follow-up blood samples.CONCLUSIONS: Prospective collection of biomaterials and associated clinical data has started in the Dutch Pancreas Biobank. Subsequent translational research will aim to improve treatment decisions based on disease characteristics.

Contains fulltext : 205352.pdf (Publisher’s version ) (Open Access) Cholecystolithiasis and functional gastrointestinal disorders are both highly prevalent in the industrialized world and may exist concomitantly. The presence of both conditions impedes identification of the source of symptoms, leading to a risk of ineffective cholecystectomies with lack of symptom resolution. We carried out a systematic review and meta-analysis to determine the prevalence of dyspepsia in patients with uncomplicated cholecystolithiasis. The electronic databases Medline, Embase, and Web of Science were searched for articles reporting the prevalence of dyspepsia in adults (>/=18 years) with uncomplicated cholecystolithiasis. Pooled prevalence and 95% confidence interval were calculated. I statistics were used to determine heterogeneity and the Methodological Evaluation of Observational Research criteria were applied for quality assessment. The study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Of the 1696 studies evaluated, 13 reported the prevalence of dyspepsia in a total of 1227 cholecystolithiasis patients seeking medical care. The pooled prevalence of dyspepsia in patients with cholecystolithiasis was 65.7% (95% confidence interval: 51-79%). However, heterogeneity was large across studies. Overall, three studies used validated diagnostic criteria. Variation in diagnostic measures significantly influenced the prevalence of dyspepsia. In conclusion, symptoms similar to those of functional gastrointestinal disorders are common in patients with cholecystolithiasis, obscuring the source of abdominal complaints. Tools to select patients who will benefit from cholecystectomy are paramount to prevent ineffective surgery.

Objective: This trial followed a structured nationwide training program in minimally invasive distal pancreatectomy (MIDP), according to the IDEAL framework for surgical innovation, and aimed to compare time to functional recovery after minimally invasive and open distal pancreatectomy (ODP).Background: MIDP is increasingly used and may enhance postoperative recovery as compared with ODP, but randomized studies are lacking.Methods: A multicenter patient-blinded randomized controlled superiority trial was performed in 14 centers between April 2015 and March 2017. Adult patients with left-sided pancreatic tumors confined to the pancreas without vascular involvement were randomly assigned (1:1) to undergo MIDP or ODP. Patients were blinded for type of surgery using a large abdominal dressing. The primary endpoint was time to functional recovery. Analysis was by intention to treat. This trial was registered with the Netherlands Trial Register (NTR5689).Results: Time to functional recovery was 4 days [interquartile range (IQR) 3-6) in 51 patients after MIDP versus 6 days (IQR 5-8) in 57 patients after ODP (P = III complication rate was 25% versus 38% (P = 0.21). Delayed gastric emptying grade B/C was seen less often after MIDP (6% vs 20%; P = 0.04). Postoperative pancreatic fistulas grade B/C were seen in 39% after MIDP versus 23% after ODP (P = 0.07), without difference in percutaneous catheter drainage (22% vs 20%; P = 0.77). Quality of life (day 3-30) was better after MIDP as compared with ODP, and overall costs were non-significantly less after MIDP. No 90-day mortality was seen after MIDP versus 2% (n = 1) after ODP.Conclusions: In patients with left-sided pancreatic tumors confined to the pancreas, MIDP reduces time to functional recovery compared with ODP. Although the overall rate of complications was not reduced, MIDP was associated with less delayed gastric emptying and better quality of life without increasing costs.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the benefits and harms of deep neuromuscular blockade on early postoperative recovery in adults undergoing laparoscopic intraperitoneal procedures.

Contains fulltext : 172481.pdf (Publisher’s version ) (Open Access) BACKGROUND: Cholecystectomy is the therapy of first choice in patients with uncomplicated symptomatic cholecystolithiasis, but it remains unclear which patients truly benefit in terms of health status improvement. Patients generally present with episodic abdominal pain of varying frequency, duration, and intensity. We assessed whether characteristics of abdominal pain episodes are determinants of clinically relevant improvement of health status after cholecystectomy. METHODS: In a post hoc analysis of a prospective multicenter cohort study, patients of >/=18 years of age with uncomplicated symptomatic cholecystolithiasis subjected to cholecystectomy were included. Preoperatively, patients received a structured interview and a questionnaire consisting of the visual analogue scale (VAS; range 0-100) and gastrointestinal quality of life index (GIQLI). At 12 weeks after cholecystectomy, the GIQLI was again administered. Logistic regression analyses were performed to determine significant associations. RESULTS: Questionnaires were sent to 261 and returned by 166 (63.6 %) patients (128 females, mean age at surgery 49.5 +/- 13.8). A total of 131 (78.9 %) patients reported a clinically relevant improvement of health status. The median (interquartile range) frequency, duration, and intensity of abdominal pain episodes were 0.38 (0.18-0.75) a week, 4.00 (2.00-8.00) hours, and 92 (77-99), respectively. None of the characteristics was associated with a clinically relevant improvement of health status at 12 weeks after cholecystectomy. CONCLUSIONS: Characteristics of abdominal pain episodes cannot be used to inform patients with symptomatic cholecystolithiasis who are skeptic about the timing of cholecystectomy for optimal benefit. Timing of cholecystectomy should therefore be based on other characteristics and preferences.

Contains fulltext : 190967.pdf (Publisher’s version ) (Closed access) BACKGROUND: Although, 33% to 40% of symptomatic gallstone patients reported persistent abdominal pain after laparoscopic cholecystectomy, there is no data on the burden of this pain to the healthcare system and society at large. This study determined healthcare consumption, sick leave, and costs in patients with persistent abdominal pain after laparoscopic cholecystectomy. Secondly, predictive factors for healthcare consumption were assessed. METHODS: This cross-sectional study included all 146 patients with persistent abdominal pain (patient-reported on Gastro-Intestinal Quality of Life Index (score 0-3) 24 weeks after laparoscopic cholecystectomy, derived from a previous prospective cohort. Healthcare consumption was assessed using Medical Consumption Questionnaire and medical records, and sick leave using Productivity Cost Questionnaire. Costs were calculated according "Guideline for performing economic evaluations in healthcare." Predictors of healthcare consumption were assessed using logistic regression analysis. RESULTS: In the study, 124/146 patients (85%) responded after mean follow-up of 31.0 months (standard deviation 6.5); 104 were female, mean age of responders was 52 years. Sixty-nine patients needed additional healthcare; 30.6% primary care; 37.1% secondary care; 16% emergency department admission; 8.9% hospital admission; 33.9% diagnostic procedures; 17.7% medication; 5.6% other interventions. Medical costs were $555 (BCa 95% confidence interval, $329-$852) and costs of sick leave were $361 (Bias-corrected and accelerated (BCa) 95% confidence interval, $189-$566) per year per patient. Younger age (odds ratio 0.95, 95% confidence interval, 0.92-0.98) and higher postoperative pain score (odds ratio 1.02, 95% confidence interval, 1.01-1.04) were associated with increased healthcare consumption. CONCLUSION: Persistent abdominal pain after laparoscopic cholecystectomy is associated with additional healthcare in 56% of patients. Yearly, medical costs and costs of sick leave are 20% of the initial costs of laparoscopic cholecystectomy.

Background Approximately 0.6% to 4% of cholecystectomies are performed because of gallbladder polyps. The decision to perform cholecystectomy is based on presence of gallbladder polyp(s) on transabdominal ultrasound (TAUS) or endoscopic ultrasound (EUS), or both. These polyps are currently considered for surgery if they grow more than 1 cm. However, non-neoplastic polyps (pseudo polyps) do not need surgery, even when they are larger than 1 cm. True polyps are neoplastic, either benign (adenomas) or (pre)malignant (dysplastic polyps/carcinomas). True polyps need surgery, especially if they are premalignant or malignant. There has been no systematic review and meta-analysis on the accuracy of TAUS and EUS in the diagnosis of gallbladder polyps, true gallbladder polyps, and (pre)malignant polyps. Objectives To summarise and compare the accuracy of transabdominal ultrasound (TAUS) and endoscopic ultrasound (EUS) for the detection of gallbladder polyps, for differentiating between true and pseudo gallbladder polyps, and for differentiating between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder in adults. Search methods We searched the Cochrane Library, MEDLINE, Embase, Science Citation Index Expanded, and trial registrations (last date of search 09 July 2018). We had no restrictions regarding language, publication status, or prospective or retrospective nature of the studies. Selection criteria Studies reporting on the diagnostic accuracy data (true positive, false positive, false negative and true negative) of the index test (TAUS or EUS or both) for detection of gallbladder polyps, differentiation between true and pseudo polyps, or differentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps. We only accepted histopathology after cholecystectomy as the reference standard, except for studies on diagnosis of gallbladder polyp. For the latter studies, we also accepted repeated imaging up to six months by TAUS or EUS as the reference standard. Data collection and analysis Two authors independently screened abstracts, selected studies for inclusion, and collected data from each study. The quality of the studies was evaluated using the QUADAS-2 tool. The bivariate random-effects model was used to obtain summary estimates of sensitivity and specificity, to compare diagnostic performance of the index tests, and to assess heterogeneity. Main results A total of 16 studies were included. All studies reported on TAUS and EUS as separate tests and not as a combination of tests. All studies were at high or unclear risk of bias, ten studies had high applicability concerns in participant selection (because of inappropriate participant exclusions) or reference standards (because of lack of follow-up for non-operated polyps), and three studies had unclear applicability concerns in participant selection (because of high prevalence of gallbladder polyps) or index tests (because of lack of details on ultrasound equipment and performance). A meta-analysis directly comparing results of TAUS and EUS in the same population could not be performed because only limited studies executed both tests in the same participants. Therefore, the results below were obtained only from indirect test comparisons. There was significant heterogeneity amongst all comparisons (target conditions) on TAUS and amongst studies on EUS for differentiating true and pseudo polyps.Detection of gallbladder polyps: Six studies (16,260 participants) used TAUS. We found no studies on EUS. The summary sensitivity and specificity of TAUS for the detection of gallbladder polyps was 0.84 (95% CI 0.59 to 0.95) and 0.96 (95% CI 0.92 to 0.98), respectively. In a cohort of 1000 people, with a 6.4% prevalence of gallbladder polyps, this would result in 37 overdiagnosed and seven missed gallbladder polyps.Differentiation between true polyp and pseudo gallbladder polyp: Six studies (1078 participants) used TAUS; the summary sensitivity was 0.68 (95% CI 0.44 to 0.85) and the summary specificity was 0.79 (95% CI 0.57 to 0.91). Three studies (209 participants) used EUS; the summary sensitivity was 0.85 (95% CI 0.46 to 0.97) and the summary specificity was 0.90 (95% CI 0.78 to 0.96). In a cohort of 1000 participants with gallbladder polyps, with 10% having true polyps, this would result in 189 overdiagnosed and 32 missed true polyps by TAUS, and 90 overdiagnosed and 15 missed true polyps by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (relative sensitivity 1.06, P = 0.70, relative specificity 1.15, P = 0.12).Differentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder: Four studies (1,009 participants) used TAUS; the summary sensitivity was 0.79 (95% CI 0.62 to 0.90) and the summary specificity was 0.89 (95% CI 0.68 to 0.97). Three studies (351 participants) used EUS; the summary sensitivity was 0.86 (95% CI 0.76 to 0.92) and the summary specificity was 0.92 (95% CI 0.85 to 0.95). In a cohort of 1000 participants with gallbladder polyps, with 5% having a dysplastic polyp/carcinoma, this would result in 105 overdiagnosed and 11 missed dysplastic polyps/carcinomas by TAUS and 76 overdiagnosed and seven missed dysplastic polyps/carcinomas by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (log likelihood test P = 0.74). Authors' conclusions Although TAUS seems quite good at discriminating between gallbladder polyps and no polyps, it is less accurate in detecting whether the polyp is a true or pseudo polyp and dysplastic polyp/carcinoma or adenoma/pseudo polyp. In practice, this would lead to both unnecessary surgeries for pseudo polyps and missed cases of true polyps, dysplastic polyps, and carcinomas. There was insufficient evidence that EUS is better compared to TAUS in differentiating between true and pseudo polyps and between dysplastic polyps/carcinomas and adenomas/pseudo polyps. The conclusions are based on heterogeneous studies with unclear criteria for diagnosis of the target conditions and studies at high or unclear risk of bias. Therefore, results should be interpreted with caution. Further studies of high methodological quality, with clearly stated criteria for diagnosis of gallbladder polyps, true polyps, and dysplastic polyps/carcinomas are needed to accurately determine diagnostic accuracy of EUS and TAUS.

Background: In the mandatory nationwide Dutch Pancreatic Cancer Audit, rates of major complications and Failure to Rescue (FTR) after pancreatoduodenectomy between low-and high-mortality hospitals are compared, and independent predictors for FTR investigated.Methods: Patients undergoing pancreatoduodenectomy in 2014 and 2015 in The Netherlands were included. Hospitals were divided into quartiles based on mortality rates. The rate of major complications (Clavien-Dindo >= 3) and death after a major complication (FTR) were compared between these quartiles. Independent predictors for FTR were identified by multivariable logistic regression analysis.Results: Out of 1.342 patients, 391 (29%) developed a major complication and in-hospital mortality was 4.2%. FTR occurred in 56 (14.3%) patients. Mortality was 0.9% in the first hospital quartile (4 hospitals, 327 patients) and 8.1% in the fourth quartile (5 hospitals, 310 patients). The rate of major complications increased by 40% (25.7% vs 35.2%) between the first and fourth hospital quartile, whereas the FTR rate increased by 560% (3.6% vs 22.9%). Independent predictors of FTR were male sex (OR = 2.1, 95% CI 1.2-3.9), age > 75 years (OR = 4.3, 1.8-10.2), BMI >= 30 (OR = 2.9, 1.3-6.6), histopathological diagnosis of periampullary cancer (OR = 2.0, 1.1-3.7), and hospital volume Conclusions: Variations in mortality between hospitals after pancreatoduodenectomy were explained mainly by differences in FTR, rather than the incidence of major complications.

Background Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy. Methods The RELAX-study is a phase IV, multicenter, double-blinded, randomized controlled trial, in which 96 patients, scheduled for living donor nephrectomy, will be randomized into two groups: one with deep and one with moderate neuromuscular blockade. Deep neuromuscular blockade is defined as a post-tetanic count of 1–2. Our primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 24 h after extubation. Discussion This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures. Trial registration clinicaltrials.gov, NCT02838134. Registered on 29 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1785-y) contains supplementary material, which is available to authorized users.

Item does not contain fulltext BACKGROUND: Formation of adhesions after peritoneal surgery results in high morbidity. Barriers to prevent adhesion are seldom applied, despite their ability to reduce the severity of adhesion formation. We evaluated the benefits and harms of four adhesion barriers that have been approved for clinical use. METHODS: In this systematic review and meta-analysis, we searched PubMed, CENTRAL, and Embase for randomised clinical trials assessing use of oxidised regenerated cellulose, hyaluronate carboxymethylcellulose, icodextrin, or polyethylene glycol in abdominal surgery. Two researchers independently identified reports and extracted data. We compared use of a barrier with no barrier for nine predefined outcomes, graded for clinical relevance. The primary outcome was reoperation for adhesive small bowel obstruction. We assessed systematic error, random error, and design error with the error matrix approach. This study is registered with PROSPERO, number CRD42012003321. FINDINGS: Our search returned 1840 results, from which 28 trials (5191 patients) were included in our meta-analysis. The risks of systematic and random errors were low. No trials reported data for the effect of oxidised regenerated cellulose or polyethylene glycol on reoperations for adhesive small bowel obstruction. Oxidised regenerated cellulose reduced the incidence of adhesions (relative risk [RR] 0.51, 95% CI 0.31-0.86). Some evidence suggests that hyaluronate carboxymethylcellulose reduces the incidence of reoperations for adhesive small bowel obstruction (RR 0.49, 95% CI 0.28-0.88). For icodextrin, reoperation for adhesive small bowel obstruction did not differ significantly between groups (RR 0.33, 95% CI 0.03-3.11). No barriers were associated with an increase in serious adverse events. INTERPRETATION: Oxidised regenerated cellulose and hyaluronate carboxymethylcellulose can safely reduce clinically relevant consequences of adhesions. FUNDING: None.

BackgroundUp to 41 % of patients report pain after cholecystectomy and in most studies follow-up for these symptoms did not exceed 5 years. The episodic nature of abdominal pain associated with symptomatic cholelithiasis warrants long-term follow-up studies. We assessed which patient and surgical factors were associated with absence of pain and patient-reported success of surgery after ≥5 years of follow-up.MethodsPatients of ≥18 years of age with symptomatic cholelithiasis, classified as ASA I or II, who had previously returned a preoperative questionnaire were sent a questionnaire consisting of the gastrointestinal quality of life index (GIQLI) and patient ratings of current versus presurgical abdominal symptoms and of surgery result. Logistic regression analysis was performed to determine associations.ResultsQuestionnaires were sent to 197 patients and returned by 126 (64.0 %) patients (73.8 % female, mean age at surgery 47.5 ± 12.2 years) at a mean of 10.0 ± 1.0 years after cholecystectomy. Absence of abdominal pain was reported by 60.3 % of the patients. Patients classified as ASA II as opposed to ASA I were less likely to report absence of pain (OR 0.41, 95 % CI 0.17–0.99). A positive rating of long-term postsurgical versus presurgical abdominal symptoms was given by 89.7 % of the patients and 90.5 % considered the cholecystectomy result to be good. No variables were significantly associated with these latter two outcome measures.ConclusionsWe found a high patient-reported surgery success rate after >5 years of follow-up after cholecystectomy despite residual abdominal pain in some of these patients. None of the patient and surgery-related characteristics were consistently associated with all three outcome measures. This discrepancy between patient’ outcomes highlights the need for realistic expectations prior to cholecystectomy.Keywords: Cholecystectomy, Cholelithiasis, Patient-reported outcome, Gastro-Intestinal Quality of Life Index, Prospective cohort study

Contains fulltext : 174259.pdf (Publisher’s version ) (Open Access) BACKGROUND: The aim of this study was to determine the cost-effectiveness of a new strategy for the preoperative detection of patients that will likely benefit from a cholecystectomy, using simple criteria that can be applied by surgeons. Criteria for a cholecystectomy indication are: (1) having episodic pain; (2) onset of pain 1 year or less before the outpatient clinic visit. METHODS: The cost-effectiveness of the new strategy was evaluated against current practice using a decision analytic model. The incremental cost-effectiveness of applying criteria for a cholecystectomy for a patient with abdominal pain and gallstones was compared to applying no criteria. The incremental cost-effectiveness ratio (ICER) was expressed as extra costs to be invested to gain one more patient with absence of pain. Scenarios were analyzed to assess the influence of applying different criteria. RESULTS: The new strategy of applying one out of two criteria resulted in a 4 % higher mean proportion of patients with absence of pain compared to current practice with similar costs. The 95 % upper limit of the ICER was euro4114 ($4633) per extra patient with relief of upper abdominal pain. Application of two out of two criteria resulted in a 3 % lower mean proportion of patients with absence of pain with lower costs. CONCLUSION: The new strategy of using one out of two strict selection criteria may be an effective but also a cost-effective method to reduce the proportion of patients with pain after cholecystectomy.

Contains fulltext : 169934.pdf (Publisher’s version ) (Open Access) BACKGROUND: Persistent postoperative pain (up to 41 %) and significant practice variation necessitate better patient selection for cholecystectomy. Patient-reported outcome measures (PROMs) are nowadays known to serve as a tool for better patient selection, although variability within these subjective outcomes may be a point for debate. This study determines associations of both the preoperative pain and patient characteristics with PROMs at 24 weeks after cholecystectomy. In order to evaluate variability of PROMs, we also determined consistency of these outcomes in time. METHODS: This prospective multicenter cohort study included adult patients diagnosed with uncomplicated symptomatic cholecystolithiasis. Twenty-four weeks after surgery, a questionnaire study was carried out, containing Gastrointestinal Quality of Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire. Results were compared to preoperative data and results 12 weeks post-cholecystectomy. Logistic regression analyses were performed to determine associations. Additional post hoc analysis on associations between preoperative selection criteria and PROMs was done. RESULTS: A total of 360 patients (85 %) responded. Postoperative absence of pain was reported by 59.2 %. Associated characteristics were symptoms

Item does not contain fulltext OBJECTIVE: To study the feasibility and impact of a nationwide training program in minimally invasive distal pancreatectomy (MIDP). SUMMARY OF BACKGROUND DATA: Superior outcomes of MIDP compared with open distal pancreatectomy have been reported. In the Netherlands (2005 to 2013) only 10% of distal pancreatectomies were in a minimally invasive fashion and 85% of surgeons welcomed MIDP training. The feasibility and impact of a nationwide training program is unknown. METHODS: From 2014 to 2015, 32 pancreatic surgeons from 17 centers participated in a nationwide training program in MIDP, including detailed technique description, video training, and proctoring on-site. Outcomes of MIDP before training (2005-2013) were compared with outcomes after training (2014-2015). RESULTS: In total, 201 patients were included; 71 underwent MIDP in 9 years before training versus 130 in 22 months after training (7-fold increase, P < 0.001). The conversion rate (38% [n = 27] vs 8% [n = 11], P < 0.001) and blood loss were lower after training and more pancreatic adenocarcinomas were resected (7 [10%] vs 28 [22%], P = 0.03), with comparable R0-resection rates (4/7 [57%] vs 19/28 [68%], P = 0.67). Clavien-Dindo score >/=III complications (15 [21%] vs 19 [15%], P = 0.24) and pancreatic fistulas (20 [28%] vs 41 [32%], P = 0.62) were not significantly different. Length of hospital stay was shorter after training (9 [7-12] vs 7 [5-8] days, P < 0.001). Thirty-day mortality was 3% vs 0% (P = 0.12). CONCLUSION: A nationwide MIDP training program was feasible and followed by a steep increase in the use of MIDP, also in patients with pancreatic cancer, and decreased conversion rates. Future studies should determine whether such a training program is applicable in other settings.

Background Cholecystectomy is the preferred treatment option for symptomatic gallstones, but the exact relationship between cholecystectomies and symptoms still is unclear. This study aimed to assess the effectiveness of elective cholecystectomy for patients with cholecystolithiasis in terms of both persistent and de novo symptoms. Methods A systematic literature search was conducted in Pubmed and Embase. The search included studies comprising patients 18 years of age or older undergoing elective cholecystectomy for symptomatic cholecystolithiasis. The proportions of symptoms after cholecystectomy were calculated and then subdivided into persistent and de novo symptoms. Results A total of 38 studies reported the presence of postcholecystectomy symptoms. The results showed that upper abdominal pain, the main indication for cholecystectomy in the majority of the patients, mostly disappeared after surgery. However, it persisted in up to 33 % of the patients and arose de novo in up to 14 %. Diarrhea (85 %) and constipation (76 %) were the persistent symptoms most often reported, whereas upper abdominal pain and vomiting were the least often reported. Flatulence (62 %) was the most often reported new symptom. However, large variations in symptoms were found between studies. Conclusions The review indicates that cholecystectomy often is ineffective with regard to persistent and de novo symptoms. The finding that the types and proportions of persistent symptoms differ from those that arise de novo suggests that this distinction may be useful in predicting which patients would and which would not benefit from a cholecystectomy. Keywords: Cholecystectomy, Cholecystolithiasis, Persistent symptoms, Review, Symptoms de novo

BACKGROUND AND AIMS: The Cochrane Hepato-Biliary Group (CHBG) is one of the 52 collaborative review groups within The Cochrane Collaboration. The activities of the CHBG focus on collecting hepato-biliary randomized clinical trials (RCT) and controlled clinical trials (CCT), and including them in systematic reviews with meta-analyses of the trials. In this overview, we present the growth of The CHBG Controlled Trials Register, as well as the systematic reviews that have been produced since March 1996. RESULTS: The CHBG register includes almost 11,000 RCT and 700 CCT publications. The earliest RCT in the register were published in 1955, and the earliest CCT in 1945. From 1945 to 1980, there were less than 100 publications each year. From 1981 to 1997, their number increased from over 100 to 600 a year. After 1997, the number of publications seems to have been decreasing. The CHBG has published 199 protocols for systematic reviews and 107 systematic reviews through to August 2009 in which 21% of the RCT and CCT were included. The CHBG reviews have been cited approximately 1200 times. CONCLUSIONS: A large amount of work has been carried out since 1996. However, there is still much to do, as the CHBG register contains a great number of RCT and CCT on topics that have not yet been systematically reviewed.

Background Surgical resection is currently the only treatment with the potential for long-term survival and cure of pancreatic cancer. Surgical resection is provided as distal pancreatectomy for cancers of the body and tail of the pancreas. It can be performed by laparoscopic or open surgery. In operations on other organs, laparoscopic surgery has been shown to reduce complications and length of hospital stay as compared with open surgery. However, concerns remain about the safety of laparoscopic distal pancreatectomy compared with open distal pancreatectomy in terms of postoperative complications and oncological clearance. Objectives To assess the benefits and harms of laparoscopic distal pancreatectomy versus open distal pancreatectomy for people undergoing distal pancreatectomy for pancreatic ductal adenocarcinoma of the body or tail of the pancreas, or both. Search methods We used search strategies to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded and trials registers until June 2015 to identify randomised controlled trials (RCTs) and non-randomised studies. We also searched the reference lists of included trials to identify additional studies. Selection criteria We considered for inclusion in the review RCTs and non-randomised studies comparing laparoscopic versus open distal pancreatectomy in patients with resectable pancreatic cancer, irrespective of language, blinding or publication status.. Data collection and analysis Two review authors independently identified trials and independently extracted data. We calculated odds ratios (ORs), mean differences (MDs) or hazard ratios (HRs) along with 95% confidence intervals (CIs) using both fixed-effect and random-effects models with RevMan 5 on the basis of intention-to-treat analysis when possible. Main results We found no RCTs on this topic. We included in this review 12 non-randomised studies that compared laparoscopic versus open distal pancreatectomy (1576 participants: 394 underwent laparoscopic distal pancreatectomy and 1182 underwent open distal pancreatectomy); 11 studies (1506 participants: 353 undergoing laparoscopic distal pancreatectomy and 1153 undergoing open distal pancreatectomy) provided information for one or more outcomes. All of these studies were retrospective cohort-like studies or case-control studies. Most were at unclear or high risk of bias, and the overall quality of evidence was very low for all reported outcomes. Differences in short-term mortality (laparoscopic group: 1/329 (adjusted proportion based on meta-analysis estimate: 0.5%) vs open group: 11/1122 (1%); OR 0.48, 95% CI 0.11 to 2.17; 1451 participants; nine studies; I2 = 0%), long-term mortality (HR 0.96, 95% CI 0.82 to 1.12; 277 participants; three studies; I2 = 0%), proportion of people with serious adverse events (laparoscopic group: 7/89 (adjusted proportion: 8.8%) vs open group: 6/117 (5.1%); OR 1.79, 95% CI 0.53 to 6.06; 206 participants; three studies; I2 = 0%), proportion of people with a clinically significant pancreatic fistula (laparoscopic group: 9/109 (adjusted proportion: 7.7%) vs open group: 9/137 (6.6%); OR 1.19, 95% CI 0.47 to 3.02; 246 participants; four studies; I2 = 61%) were imprecise. Differences in recurrence at maximal follow-up (laparoscopic group: 37/81 (adjusted proportion based on meta-analysis estimate: 36.3%) vs open group: 59/103 (49.5%); OR 0.58, 95% CI 0.32 to 1.05; 184 participants; two studies; I2 = 13%), adverse events of any severity (laparoscopic group: 33/109 (adjusted proportion: 31.7%) vs open group: 45/137 (32.8%); OR 0.95, 95% CI 0.54 to 1.66; 246 participants; four studies; I2 = 18%) and proportion of participants with positive resection margins (laparoscopic group: 49/333 (adjusted proportion based on meta-analysis estimate: 14.3%) vs open group: 208/1133 (18.4%); OR 0.74, 95% CI 0.49 to 1.10; 1466 participants; 10 studies; I2 = 6%) were also imprecise. Mean length of hospital stay was shorter by 2.43 days in the laparoscopic group than in the open group (MD -2.43 days, 95% CI -3.13 to -1.73; 1068 participants; five studies; I2 = 0%). None of the included studies reported quality of life at any point in time, recurrence within six months, time to return to normal activity and time to return to work or blood transfusion requirements. Authors' conclusions Currently, no randomised controlled trials have compared laparoscopic distal pancreatectomy versus open distal pancreatectomy for patients with pancreatic cancers. In observational studies, laparoscopic distal pancreatectomy has been associated with shorter hospital stay as compared with open distal pancreatectomy. Currently, no information is available to determine a causal association in the differences between laparoscopic versus open distal pancreatectomy. Observed differences may be a result of confounding due to laparoscopic operation on less extensive cancer and open surgery on more extensive cancer. In addition, differences in length of hospital stay are relevant only if laparoscopic and open surgery procedures are equivalent oncologically. This information is not available currently. Thus, randomised controlled trials are needed to compare laparoscopic distal pancreatectomy versus open distal pancreatectomy with at least two to three years of follow-up. Such studies should include patient-oriented outcomes such as short-term mortality and long-term mortality (at least two to three years); health-related quality of life; complications and the sequelae of complications; resection margins; measures of earlier postoperative recovery such as length of hospital stay, time to return to normal activity and time to return to work (in those who are employed); and recurrence of cancer.

Contains fulltext : 154406.pdf (Publisher’s version ) (Closed access) BACKGROUND: As many as 33% of patients with symptomatic cholelithiasis report persisting abdominal pain after cholecystectomy, suggesting alternative causes of these symptoms. EGD may serve as a tool to identify additional symptomatic abdominal disorders beforehand to avoid unnecessary gallbladder surgery. There is controversy as to whether routine EGD before cholecystectomy is appropriate. OBJECTIVE: To perform a systematic review and meta-analysis to assess the value of EGD before cholecystectomy. DESIGN: A systematic literature search was conducted to identify studies that reported the proportion of patients who were referred for cholecystectomy, but in whom initial surgery could be avoided after treatment of abnormalities detected with EGD. Pooled estimates with 95% confidence intervals (CIs) were calculated by using random-effects models. SETTING: Meta-analysis of 12 cohort studies. PATIENTS: A total of 6317 patients with cholelithiasis underwent EGD. RESULTS: The pooled estimate of abnormalities detected with EGD was 36.3% (95% CI, 28.0-45.0). In a total of 3.8% (95% CI, 1.4-7.6) of patients referred for cholecystectomy who underwent previous EGD, gallbladder surgery was avoided. LIMITATIONS: Lack of information regarding characteristics of patients referred for cholecystectomy, criteria for performing EGD, algorithms for the treatment of identified pathologies, and response criteria for the decision to avoid cholecystectomy in included studies. CONCLUSIONS: Our study indicates that, despite the high diagnostic yield of EGD, its value as a tool to prevent gallbladder surgery is limited. EGD should only be considered selectively in patients with cholelithiasis referred for cholecystectomy.

The surgical treatment of choice for ulcerative colitis is colectomy followed by ileostomy or the construction of an ileo-anal pouch, which results in an improvement in quality of life. The pouch can be constructed in one operation after a total colectomy or in two steps: first, constructing an ileostomy after a subtotal colectomy and second, constructing the pouch after a proctectomy. The most common pouch-related diseases include surgical complications such as abscesses, fistulas and leaks, and inflammatory complications like pouchitis, cuffitis and Crohn's disease of the pouch. The most important diagnostic tool to differentiate between the often difficult to distinguish pouch-related diseases is a pouchoscopy. There are no evidence-based treatment strategies for pouch-related diseases due to the lack of large randomized placebo-controlled trials. Pouch-related diseases can lead to pouch failure which may require surgical reintervention with revision or excision of the pouch.

The frequency of certain medical procedures and their results vary strongly between countries, and also between regions within one country. These variations in clinical practice mean the quality of healthcare is suboptimal, result in unnecessary expense and patients are at risk of complications caused by unnecessary interventions. Patient Reported Outcome Measures (PROMs) are an instrument to clarify if a patient has benefited from a certain treatment. Systematic measurement of PROMs is necessary to show relevant differences in the effect of a therapy. If data of differences in results are combined with those of regional variations in clinical practice, it will become clear where too much or too less is treated. We expect that the systematic measurement of PROMs will make a valuable contribution to improving the quality of Dutch healthcare.

Background: Compared to subgroup analyses in a single study or in a traditional meta-analysis, an individual patient data meta-analysis (IPDMA) offers important potential advantages. We studied how many IPDMAs report on surgical interventions, how many of those surgical IPDMAs perform subgroup analyses, and whether these subgroup analyses have changed decision-making in clinical practice. Methods: Surgical IPDMAs were identified using a comprehensive literature search. The last search was conducted on 24 April 2012. For each IPDMA included, we obtained information using a standardized data extraction form, and the quality of reporting was assessed. We also checked whether results were implemented in clinical guidelines. Results: Of all 583 identified IPDMAs, 22 (4%) reported on a surgical intervention. Eighteen (82%) of these IPDMAs presented subgroup analyses. Subgroups were mainly based on patient and disease characteristics. The median number of reported subgroup analyses was 3.5 (IQR 1.25-6.5). Statistical methods for subgroup analyses were mentioned in 11 (61%) surgical IPDMAs. Eleven (61%) of the 18 IPDMAs performing subgroup analyses reported a significant overall effect estimate, whereas six (33%) reported a non-significant one. Of the IPDMAs that reported non-significant overall results, three IPDMAs (50%) reported significant results in one or more subgroup analyses. Results remained significant in one or more subgroups in eight of the IPDMAs (73%) that reported a significant overall result. Eight (44%) of the 18 significant subgroups appeared to be implemented in clinical guidelines. The quality of reporting among surgical IPDMAs varied from low to high quality. Conclusion: Many of the surgical IPDMAs performed subgroup analyses, but overall treatment effects were more often emphasized than subgroup effects. Although, most surgical IPDMAs included in the present study have only recently been published, about half of the significant subgroups were already implemented in treatment guidelines.

Contains fulltext : 89918.pdf (Publisher’s version ) (Open Access) BACKGROUND: Patients with symptomatic cholecystolithiasis are treated by three different techniques of cholecystectomy: open, small-incision, or laparoscopic. There is no overview on Cochrane systematic reviews on these three interventions. OBJECTIVES: To summarise Cochrane reviews that assess the effects of different techniques of cholecystectomy for patients with symptomatic cholecystolithiasis. METHODS: The Cochrane Database of Systematic Reviews (CDSR) was searched for all systematic reviews evaluating any interventions for the treatment of symptomatic cholecystolithiasis (Issue 4 2008). MAIN RESULTS: Three systematic reviews that included a total of 56 randomised trials with 5246 patients are included in this overview of reviews. All three reviews used identical inclusion criteria for trials and participants, and identical methodological assessments.Laparoscopic versus small-incision cholecystectomy Thirteen trials with 2337 patients randomised studied this comparison. Bias risk was relatively low. There was no significant difference regarding mortality or complications. Total complications of laparoscopic and small-incision cholecystectomy were high, ie, 17.0% and 17.5%. Total complications (risk difference, random-effects model -0.01 (95% confidence interval (CI) -0.07 to 0.05)), hospital stay (mean difference (MD), random-effects -0.72 days (95% CI -1.48 to 0.04)), and convalescence were not significantly different. Trials with low risk of bias showed a quicker operative time for small-incision cholecystectomy (MD, low risk of bias considering 'blinding', random-effects model 16.4 minutes (95% CI 8.9 to 23.8)) while trials with high risk of bias showed no statistically significant difference.Laparoscopic versus open cholecystectomy Thirty-eight trials with 2338 patients randomised studied this comparison. Bias risk was high. Laparoscopic cholecystectomy patients had a shorter hospital stay (MD, random-effects model -3 days (95% CI -3.9 to -2.3)) and convalescence (MD, random-effects model -22.5 days (95% CI -36.9 to -8.1)) compared with open cholecystectomy but did not differ significantly regarding mortality, complications, and operative time.Small-incision versus open cholecystectomy Seven trials with 571 patients randomised studied this comparison. Bias risk was high. Small-incision cholecystectomy had a shorter hospital stay (MD, random-effects model -2.8 days (95% CI -4.9 to -0.6)) compared with open cholecystectomy but did not differ significantly regarding complications and operative time. AUTHORS' CONCLUSIONS: No statistically significant differences in the outcome measures of mortality and complications have been found among open, small-incision, and laparoscopic cholecystectomy. There were no data on symptom relief. Complications in elective cholecystectomy are high. The quicker recovery of both laparoscopic and small-incision cholecystectomy patients compared with patients on open cholecystectomy justifies the existing preferences for both minimal invasive techniques over open cholecystectomy. Laparoscopic and small-incision cholecystectomies seem to be comparable, but the latter has a significantly shorter operative time, and seems to be less costly.

Item does not contain fulltext OBJECTIVE: Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision cholecystectomy regarding different outcome measures for the occurrence of type I errors. STUDY DESIGN AND SETTING: Using TSA, we calculated the required information size (IS) and the trial sequential monitoring boundaries regarding complications in our Cochrane review with meta-analyses of cholecystectomy. For each outcome, we calculated a low risk of bias heterogeneity-adjusted IS. As a sensitivity analysis, we calculated an a priori heterogeneity-adjusted IS. RESULTS: According to the trial sequential analyses based on a low risk of bias heterogeneity-adjusted IS definitive evidence may be reached by conducting one more randomized trial. Information may be required on 582 and 119 additional randomized patients to evaluate the effect on severe complications and serious adverse events (SAEs), respectively. CONCLUSION: Our results provide incentives to conduct a new trial with a low risk of bias focusing on a new composite outcome measure of SAEs to obtain conclusive evidence on which operative method to recommend. 01 maart 2010

Contains fulltext : 87299.pdf (Publisher’s version ) (Open Access) BACKGROUND: Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach. METHODS: In this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death. RESULTS: The primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P=0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P=0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P=0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P=0.03) and new-onset diabetes (16% vs. 38%, P=0.02). CONCLUSIONS: A minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)

Contains fulltext : 88310.pdf (Publisher’s version ) (Open Access) BACKGROUND: Cholecystectomy causes considerable financial burden on society with a major part caused by sick-leave. There are wide variations in duration of sick-leave. The aim of our study was to identify all aspects that influence the moment of return to work by using focus groups and to compare responses from patients and physicians. METHODS: A qualitative research design was planned using focus group discussions. Four focus group discussions were organized: two patient groups and two physician groups. Employed patients who had recovered after cholecystectomy were included in the patient groups. The physicians groups consisted of general practitioners, surgeons, and company physicians. Three investigators independently searched transcriptions of the sessions for all items relating to return to work. The importance of items and categories were assessed by determining frequencies. RESULTS: In the patients groups physical limitations (35.3%) and individual patient factors (17.5%) were important factors in the duration of sick-leave, while influence or advice comprised only 8.4% of the items. In the physicians groups influence or advice (21.8%) and information-related factors (21.4%) were thought to be important categories. CONCLUSIONS: Physicians perceive their advices as an important factor in patients' duration of sick-leave. In contrast, patients seldom mention this factor and experience physical complaints as the major reason influencing the moment of return to work.

OBJECTIVE: To evaluate the primary and clinical outcomes in laparoscopic and small-incision cholecystectomy. DESIGN: Blinded randomized single-center trial emphasizing methodologic quality and generalizability. SETTING: General teaching hospital in the Netherlands. PATIENTS: A total of 257 patients undergoing cholecystectomy for symptomatic cholecystolithiasis. INTERVENTIONS: Laparoscopic cholecystectomy and small-incision cholecystectomy, performed mainly by surgical residents. MAIN OUTCOME MEASURES: Complications and symptom relief were primary outcome measures; conversion rate, operative time, and hospital stay were secondary outcome measures. Feasibility of performing both procedures by residents was evaluated as well. RESULTS: In the 257 patients, surgical residents performed 105 laparoscopic and 118 small-incision cholecystectomies. There were no significant differences in complications, conversion rates, and hospital stay. Operative time was significantly shorter with the small-incision technique. CONCLUSIONS: No differences in primary clinical outcome measures were found between laparoscopic and small-incision cholecystectomy in this randomized trial with emphasis on methodologic quality and generalizability. The gold standard status of laparoscopic cholecystectomy is questionable. Trial Registration isrctn.org Identifier: ISRCTN67485658.

Contains fulltext : 69536.pdf (Publisher’s version ) (Open Access) BACKGROUND: Gallstones are a major cause of morbidity, and cholecystectomy is a commonly performed procedure. Minimal invasive procedures, laparoscopic cholecystectomy (LC) and small-incision cholecystectomy (SIC), have replaced the classical open cholecystectomy. No differences have been found in primary outcome measures between LC and SIC, therefore secondary outcome measures have to be considered to determine preferences. The aim of our study was to examine health status applying evidence-based guidelines in LC and SIC in a randomised trial. METHODS: Patients with symptomatic cholecystolithiasis were included in a blind randomised trial. Operative procedures, anaesthesia, analgesics and postoperative care were standardised in order to limit bias. Questionnaires were filled in preoperatively, the first day postoperatively, and at outpatients follow-up at 2, 6 and 12 weeks. In accordance with evidence-based guidelines, the generic short form (SF-36) and the disease-specific gastrointestinal quality-of-life index (GIQLI) questionnaires were used in addition to the body image questionnaire (BIQ). RESULTS: A total of 257 patients were randomised between LC (120) and SIC (137). Analyses were performed according to intention-to-treat (converted procedures included) and also distinguishing converted from minimal invasive (nonconverted) procedures. Questionnaires were obtained with a response rate varying from 87.5% preoperatively to 77.4% three months postoperatively. Except for two time-specific measurements in one SF-36 subscale, there were no differences between LC and SIC. There were significant differences in several subscales in all three questionnaires comparing minimal invasive versus converted procedures. CONCLUSIONS: Applying adequate methodological quality and evidence-based guidelines (by using SF-36 and GIQLI), there are no significant differences in health status between LC and SIC.

Contains fulltext : 109649.pdf (Publisher’s version ) (Open Access) BACKGROUND: The annual incidence of ankle fractures is 122 per 100,000 people. They usually affect young men and older women. The question of whether surgery or conservative treatment should be used for ankle fractures remains controversial. OBJECTIVES: To assess the effects of surgical versus conservative interventions for treating ankle fractures in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2012 Issue 1), MEDLINE, EMBASE, CINAHL and the WHO International Clinical Trials Registry Platform and Current Controlled Trials. Date of last search: 6 February 2012. SELECTION CRITERIA: Randomised and quasi-randomised controlled clinical studies comparing surgical and conservative treatments for ankle fractures in adults were included. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. Authors of the included studies were contacted to obtain original data. MAIN RESULTS: Three randomised controlled trials and one quasi-randomised controlled trial were included. These involved a total of 292 participants with ankle fractures. All studies were at high risk of bias from lack of blinding. Additionally, loss to follow-up or inappropriate exclusion of participants put two trials at high risk of attrition bias. The trials used different and incompatible outcome measures for assessing function and pain. Only limited meta-analysis was possible for early treatment failure, some adverse events and radiological signs of arthritis.One trial, following up 92 of 111 randomised participants, found no statistically significant differences between surgery and conservative treatment in patient-reported symptoms (self assessed ankle "troubles": 11/43 versus 14/49; risk ratio (RR) 0.90, 95% CI 0.46 to 1.76) or walking difficulties at seven years follow-up. One trial, reporting data for 31 of 43 randomised participants, found a statistically significantly better mean Olerud score in the surgically treated group but no difference between the two groups in pain scores after a mean follow-up of 27 months. A third trial, reporting data for 49 of 96 randomised participants at 3.5 years follow-up, reported no difference between the two groups in a non-validated clinical score.Early treatment failure, generally reflecting the failure of closed reduction (criteria not reported in two trials) probably or explicitly leading to surgery in patients allocated conservative treatment, was significantly higher in the conservative treatment group (2/116 versus 19/129; RR 0.18, 95% CI 0.06 to 0.54). Otherwise, there were no statistically significant differences between the two groups in any of the reported complications. Pooled results from two trials of participants with radiological signs of osteoarthritis at averages of 3.5 and 7.0 years follow-up showed no between-group differences (44/66 versus 50/75; RR 1.05, 95% CI 0.83 to 1.31). AUTHORS' CONCLUSIONS: There is currently insufficient evidence to conclude whether surgical or conservative treatment produces superior long-term outcomes for ankle fractures in adults. The identification of several ongoing randomised trials means that better evidence to inform this question is likely to be available in future.

Contains fulltext : 95900.pdf (Publisher’s version ) (Open Access) BACKGROUND: In recent years the Enhanced Recovery after Surgery (ERAS) postoperative pathway in (ileo-)colorectal surgery, aiming at improving perioperative care and decreasing postoperative complications, has become more common. OBJECTIVES: We investigated the effectiveness and safety of the ERAS multimodal strategy, compared to conventional care after (ileo-)colorectal surgery. The primary research question was whether ERAS protocols lead to less morbidity and secondary whether length of stay was reduced. SEARCH STRATEGY: To answer the research question we entered search strings containing keywords like "fast track", "colorectal and surgery" and "enhanced recovery" into major databases. We also hand searched references in identified reviews concerning ERAS. SELECTION CRITERIA: We included published randomised clinical trials, in any language, comparing ERAS to conventional treatment in patients with (ileo-) colorectal disease requiring a resection. RCT's including at least 7 ERAS items in the ERAS group and no more than 2 in the conventional arm were included. DATA COLLECTION AND ANALYSIS: Data of included trials were independently extracted by the reviewers. Analyses were performed using "REVMAN 5.0.22". Data were pooled and rate differences as well as weighted mean differences with their 95% confidence intervals were calculated using either fixed or random effects models, depending on heterogeneity (I(2)). MAIN RESULTS: 4 RCTs were included and analysed. Methodological quality of included studies was considered low, when scored according to GRADE methodology. Total numbers of inclusion were limited. The trials included in primary analysis reported 237 patients, (119 ERAS vs 118 conventional). Baseline characteristics were comparable. The primary outcome measure, complications, showed a significant risk reduction for all complications (RR 0.50; 95% CI 0.35 to 0.72). This difference was not due to reduction in major complications. Length of hospital stay was significantly reduced in the ERAS group (MD -2.94 days; 95% CI -3.69 to -2.19), and readmission rates were equal in both groups. Other outcome parameters were unsuitable for meta-analysis, but seemed to favour ERAS. AUTHORS' CONCLUSIONS: The quantity and especially quality of data are low. Analysis shows a reduction in overall complications, but major complications were not reduced. Length of stay was reduced significantly. We state that ERAS seems safe, but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the standard of care. Within ERAS protocols included, no answer regarding the role for minimally invasive surgery (i.e. laparoscopy) was found. Furthermore, protocol compliance within ERAS programs has not been investigated, while this seems a known problem in the field. Therefore, more specific and large RCT's are needed.

Contains fulltext : 88651.pdf (Publisher’s version ) (Open Access) BACKGROUND: Clinical evidence continues to expand and is increasingly difficult to overview. We aimed at conceptualizing a visual assessment tool, i.e., a matrix for overviewing studies and their data in order to assess the clinical evidence at a glance. METHODS: A four-step matrix was constructed using the three dimensions of systematic error, random error, and design error. Matrix step I ranks the identified studies according to the dimensions of systematic errors and random errors. Matrix step II orders the studies according to the design errors. Matrix step III assesses the three dimensions of errors in studies. Matrix step IV assesses the size and direction of the intervention effect. RESULTS: The application of this four-step matrix is illustrated with two examples: peri-operative beta-blockade initialized in relation to surgery versus placebo for major non-cardiac surgery, and antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. When clinical evidence is deemed both internally and externally valid, the size of the intervention effect is to be assessed. CONCLUSION: The error matrix provides an overview of the validity of the available evidence at a glance, and may assist in deciding which interventions to use in clinical practice.

Contains fulltext : 79609.pdf (Publisher’s version ) (Open Access) BACKGROUND: After its introduction, laparoscopic cholecystectomy rapidly expanded around the world and was accepted the procedure of choice by consensus. However, analysis of evidence shows no difference regarding primary outcome measures between laparoscopic and small-incision cholecystectomy. In absence of clear clinical benefit it may be interesting to focus on the resource use associated with the available techniques, a secondary outcome measure. This study focuses on a difference in costs between laparoscopic and small-incision cholecystectomy from a societal perspective with emphasis on internal validity and generalisability METHODS: A blinded randomized single-centre trial was conducted in a general teaching hospital in The Netherlands. Patients with reasonable to good health diagnosed with symptomatic cholecystolithiasis scheduled for cholecystectomy were included. Patients were randomized between laparoscopic and small-incision cholecystectomy. Total costs were analyzed from a societal perspective. RESULTS: Operative costs were higher in the laparoscopic group using reusable laparoscopic instruments (difference 203 euro; 95% confidence interval 147 to 259 euro). There were no significant differences in the other direct cost categories (outpatient clinic and admittance related costs), indirect costs, and total costs. More than 60% of costs in employed patients were caused by sick leave. CONCLUSION: Based on differences in costs, small-incision cholecystectomy seems to be the preferred operative technique over the laparoscopic technique both from a hospital and societal cost perspective. Sick leave associated with convalescence after cholecystectomy in employed patients results in considerable costs to society. TRIAL REGISTRATION: ISRCTN Register, number ISRCTN67485658.