Changes in nutrient composition and diet quality in the first 6 months following bariatric surgery: An observational cohort study.

BACKGROUND: Bariatric surgery (BS) may result in inadequate nutrient intake and poor diet quality, which can lead to nutritional complications. The present study aimed to evaluate changes in macro- and micronutrient composition and diet quality in the first 6 months following BS. METHODS: One hundred seven participants undergoing BS (Roux-en-Y gastric bypass: n = 87, sleeve gastrectomy: n = 20) completed 3-day food records before and 6 months after surgery. Changes in energy, macronutrient (carbohydrates, protein, fat, dietary fibre) and micronutrient intake (folate, vitamin B12, vitamin D, calcium, iron) were evaluated. Diet quality was assessed by adherence to the Dutch food-based dietary guidelines. RESULTS: After BS, we observed a significant decrease in intake of energy and all macro- and micronutrients (p < 0.01 for all), except for calcium (-39.0 ± 404.6 mg; p = 0.32). Overall, nutrient composition slightly changed with an increase in the relative intake of protein (+1.1 ± 4.3 energy percentage [en%]; p = 0.01) and mono- and disaccharides (+4.2 ± 6.4 en%; p < 0.001) post-surgery. Consumption (median [Q1, Q3]) of vegetables (-50 [-120, 6] g day-1 ), wholegrain products (-38 [-81, -8] g day-1 ), liquid fats (-5 [-13, 2] g day-1 ), red meat (-3 [-30, 4] g day-1 ), processed meat (-32 [-55, 13] g day-1 ), sodium (-0.7 [-1.1, -0.2] g day-1 ) and unhealthy food choices (-2.4 [-5.0, 0.6] serves week-1 ) significantly decreased after BS (p < 0.01 for all). CONCLUSIONS: Our results demonstrate both favourable and unfavourable changes in macro- and micronutrient composition and diet quality in the first 6 months following BS. Insight into these changes can improve dietary counselling in this population. Future research into underlying causes, consequences and long-term changes in dietary intake is needed.

EAES Multidisciplinary Rapid Guideline: systematic review, meta-analysis, GRADE assessment and evidence-informed recommendations on the surgical management of paraesophageal hernias.

BACKGROUND: New evidence has emerged since latest guidelines on the management of paraesophageal hernia, and guideline development methodology has evolved. Members of the European Association for Endoscopic Surgery have prioritized the management of paraesophageal hernia to be addressed by pertinent recommendations. OBJECTIVE: To develop evidence-informed clinical practice recommendations on paraesophageal hernias, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: We performed three systematic reviews, and we summarized and appraised the certainty of the evidence using the GRADE methodology. A panel of general and upper gastrointestinal surgeons, gastroenterologists and a patient advocate discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost and use of resources, moderated by a Guidelines International Network-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests surgery over conservative management for asymptomatic/minimally symptomatic paraesophageal hernias (conditional recommendation), and recommends conservative management over surgery for asymptomatic/minimally symptomatic paraesophageal hernias in frail patients (strong recommendation). Further, the panel suggests mesh over sutures for hiatal closure in paraesophageal hernia repair, fundoplication over gastropexy in elective paraesophageal hernia repair, and gastropexy over fundoplication in patients who have cardiopulmonary instability and require emergency paraesophageal hernia repair (conditional recommendation). A strong recommendation means that the proposed course of action is appropriate for the vast majority of patients. A conditional recommendation means that most patients would opt for the proposed course of action, and joint decision-making of the surgeon and the patient is required. Accompanying evidence summaries and evidence-to-decision frameworks should be read when using the recommendations. This guideline applies to adult patients with moderate to large paraesophageal hernias type II to IV with at least 50% of the stomach herniated to the thoracic cavity. The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/j7q7Gn . CONCLUSION: An interdisciplinary panel provides recommendations on key topics on the management of paraesophageal hernias using highest methodological standards and following a transparent process. GUIDELINE REGISTRATION NUMBER: PREPARE-2023CN018.

Bariatric surgery and cardiovascular disease: a systematic review and meta-analysis.

AIMS: Obesity is a global health problem, associated with significant morbidity and mortality, often due to cardiovascular (CV) diseases. While bariatric surgery is increasingly performed in patients with obesity and reduces CV risk factors, its effect on CV disease is not established. We conducted a systematic review and meta-analysis to evaluate the effect of bariatric surgery on CV outcomes, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. METHODS AND RESULTS: PubMed and Embase were searched for literature until August 2021 which compared bariatric surgery patients to non-surgical controls. Outcomes of interest were all-cause and CV mortality, atrial fibrillation (AF), heart failure (HF), myocardial infarction, and stroke. We included 39 studies, all prospective or retrospective cohort studies, but randomized outcome trials were not available. Bariatric surgery was associated with a beneficial effect on all-cause mortality [pooled hazard ratio (HR) of 0.55; 95% confidence interval (CI) 0.49-0.62, P < 0.001 vs. controls], and CV mortality (HR 0.59, 95% CI 0.47-0.73, P < 0.001). In addition, bariatric surgery was also associated with a reduced incidence of HF (HR 0.50, 95% CI 0.38-0.66, P < 0.001), myocardial infarction (HR 0.58, 95% CI 0.43-0.76, P < 0.001), and stroke (HR 0.64, 95% CI 0.53-0.77, P < 0.001), while its association with AF was not statistically significant (HR 0.82, 95% CI 0.64-1.06, P = 0.12). CONCLUSION: The present systematic review and meta-analysis suggests that bariatric surgery is associated with reduced all-cause and CV mortality, and lowered incidence of several CV diseases in patients with obesity. Bariatric surgery should therefore be considered in these patients.

Bariatric surgery stigma from the perspective of patients: A scoping review.

AIMS: To explore the experiences and consequences of bariatric surgery stigma from the perspective of bariatric surgery patients and to identify knowledge gaps in the literature. DESIGN: A scoping review. DATA SOURCES: Studies published between December 2002 and January 2022 were identified from the following databases: PubMed, Web of Science, PsycINFO and MEDLINE. REVIEW METHODS: We screened 3092 records and included 28 studies. Findings were grouped thematically using the health stigma discrimination framework. RESULTS: Patients experienced several types of stigmas, including perceived, experienced, anticipated and internalized stigma, related to undergoing bariatric surgery. Patients were confronted with negative comments and judgement from others when they disclosed their decision to have surgery or when they revealed that they had undergone surgery. These experiences led to conflicts in the decision-making process, such as delaying the choice for surgery, seeking surgery abroad or opting out. Patients who internalized stigma often reported feelings of shame and embarrassment for choosing surgery and felt the need for secrecy or selective disclosure. Stigma experiences were influenced by gender and differed between different subgroups of patients. CONCLUSION: The stigma surrounding bariatric surgery has detrimental consequences for eligible individuals and bariatric surgery patients. However, the evidence from patients' perspective remains limited. More research into patient's experiences is needed to improve patient care and further educate healthcare professionals. In addition, to better understand the nature and implications of bariatric surgery stigma, future research should be founded on stigma theories and distinguish between the different types of stigmas. IMPACT: This scoping review contributes to a better understanding of the implications the stigma surrounding bariatric surgery has for bariatric surgery patients before and after surgery. The knowledge generated by this review can inform improvements in the education and management of people living with obesity and bariatric surgery patients. REPORTING METHOD: The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution. PROTOCOL REGISTRATION: A protocol was not registered for this scoping review.

Pneumatic dilation for persistent dysphagia after antireflux surgery, a multicentre single-blind randomised sham-controlled clinical trial.

OBJECTIVE: There is no evidence-based treatment for persistent dysphagia after laparoscopic fundoplication. The aim of this study was to evaluate the effect of pneumatic dilation on persistent dysphagia after laparoscopic fundoplication. DESIGN: We performed a multicentre, single-blind, randomised sham-controlled trial of patients with persistent dysphagia (>3 months) after laparoscopic fundoplication. Patients with an Eckardt symptom score ≥4 were randomly assigned to pneumatic dilation (PD) using a 35 mm balloon or sham dilation. Primary outcome was treatment success, defined as an Eckardt score <4 and a minimal reduction of 2 points in the Eckardt score after 30 days. Secondary outcomes included change in stasis on timed barium oesophagogram, change in high-resolution manometry parameters and questionnaires on quality of life, reflux and dysphagia symptoms. RESULTS: Forty-two patients were randomised. In the intention-to-treat analysis, the success rates of PD (7/21 patients (33%)) and sham dilation (8/21 patients (38%)) were similar after 30 days (risk difference -4.7% (95% CI (-33.7% to 24.2%) p=0.747). There was no significant difference in change of stasis on the timed barium oesophagogram after 2 min (PD vs sham: median 0.0 cm, p25-p75 range 0.0-4.3 cm vs median 0.0 cm, p25-p75 range 0.0-0.0; p=0.122) or change in lower oesophageal sphincter relaxation pressure (PD vs sham: 10.54±6.25 vs 14.60±6.17 mm Hg; p=0.052). Quality of life, reflux and dysphagia symptoms were not significantly different between the two groups. CONCLUSION: Pneumatic dilation with a 35 mm balloon is not superior to sham dilation for the treatment of persistent dysphagia after fundoplication.

Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial).

OBJECTIVE: To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state. SUMMARY BACKGROUND DATA: More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome. METHODS: We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6 months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. RESULTS: We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001. CONCLUSIONS: One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process. TRIAL REGISTRATION: The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.

Relative validity of a short screener to assess diet quality in patients with severe obesity before and after bariatric surgery.

OBJECTIVE: To determine the relative validity and reproducibility of the Eetscore FFQ, a short screener for assessing diet quality, in patients with (severe) obesity before and after bariatric surgery (BS). DESIGN: The Eetscore FFQ was evaluated against 3-d food records (3d-FR) before (T0) and 6 months after BS (T6) by comparing index scores of the Dutch Healthy Diet index 2015 (DHD2015-index). Relative validity was assessed using paired t tests, Kendall's tau-b correlation coefficients (τb), cross-classification by tertiles, weighted kappa values (k w ) and Bland-Altman plots. Reproducibility of the Eetscore FFQ was assessed using intraclass correlation coefficients (ICC). SETTING: Regional hospital, the Netherlands. PARTICIPANTS: Hundred and forty participants with obesity who were scheduled for BS. RESULTS: At T0, mean total DHD2015-index score derived from the Eetscore FFQ was 10·2 points higher than the food record-derived score (P < 0·001) and showed an acceptable correlation (τb = 0·42, 95 % CI: 0·27, 0·55). There was a fair agreement with a correct classification of 50 % (k w = 0·37, 95 % CI: 0·25, 0·49). Correlation coefficients of the individual DHD components varied from 0·01-0·54. Similar results were observed at T6 (τb = 0·31, 95 % CI: 0·12, 0·48, correct classification of 43·7 %; k w = 0·25, 95 % CI: 0·11, 0·40). Reproducibility of the Eetscore FFQ was good (ICC = 0·78, 95 % CI: 0·69, 0·84). CONCLUSION: The Eetscore FFQ showed to be acceptably correlated with the DHD2015-index derived from 3d-FR, but absolute agreement was poor. Considering the need for dietary assessment methods that reduce the burden for patients, practitioners and researchers, the Eetscore FFQ can be used for ranking according to diet quality and for monitoring changes over time.

Defining Global Benchmarks in Elective Secondary Bariatric Surgery Comprising Conversional, Revisional, and Reversal Procedures.

OBJECTIVE: To define "best possible" outcomes for secondary bariatric surgery (BS). BACKGROUND: Management of poor response and of long-term complications after BS is complex and under-investigated. Indications and types of reoperations vary widely and postoperative complication rates are higher compared to primary BS. METHODS: Out of 44,884 BS performed in 18 high-volume centers from 4 continents between 06/2013-05/2019, 5,349 (12%) secondary BS cases were identified. Twenty-one outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of centers. Benchmark cases had no previous laparotomy, diabetes, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, thromboembolic events, BMI> 50 kg/m2 or age> 65 years. RESULTS: The benchmark cohort included 3143 cases, mainly females (85%), aged 43.8 ±â€Š10 years, 8.4 ±â€Š5.3 years after primary BS, with a BMI 35.2 ±â€Š7 kg/m2. Main indications were insufficient weight loss (43%) and gastro-esophageal reflux disease/dysphagia (25%). 90-days postoperatively, 14.6% of benchmark patients presented ≥1 complication, mortality was 0.06% (n = 2). Significantly higher morbidity was observed in non-benchmark cases (OR 1.37) and after conversional/reversal or revisional procedures with gastrointestinal suture/stapling (OR 1.84). Benchmark cutoffs for conversional BS were ≤4.5% re-intervention, ≤8.3% re-operation 90-days postoperatively. At 2-years (IQR 1-3) 15.6% of benchmark patients required a reoperation. CONCLUSION: Secondary BS is safe, although postoperative morbidity exceeds the established benchmarks for primary BS. The excess morbidity is due to an increased risk of gastrointestinal leakage and higher need for intensive care. The considerable rate of tertiary BS warrants expertise and future research to optimize the management of non-success after BS.

Delayed surgical resection of primary left-sided obstructing colon cancer is associated with improved short- and long-term outcomes.

BACKGROUND AND OBJECTIVES: It is unclear what time interval is optimal between presentation and surgical resection of left-sided obstructive colon cancer (LSOCC). This study aims to determine whether a time interval beyond 4 weeks is associated with a better outcome. MATERIALS AND METHODS: Consecutive patients who underwent surgical resection of LSOCC between January 2010 and December 2019 were collected from a prospective database. Patients were divided into three groups: (1) Emergency resection (ER group), (2) surgery in less than 4 weeks (early group), and (3) surgery beyond 4 weeks (late group). RESULTS: The ER group consisted of 74 (44.0%), the early group of 38 (22.6%), and the late group of 56 (33.3%) patients. Ninety-day mortality was lower in the Late group than in the ER group and the early group (1.8% vs. 12.2%, p = 0.029 vs. 15.3%, p = 0.011). In the late group 5-year recurrence-free survival was better than in the early group (82.1% vs. 63.2%, p = 0.039) and 5-year overall survival (OS) was better than in the ER group (75% vs. 51.4%, p = 0.021). Definitive surgical resection beyond 4 weeks was an independent prognostic factor for OS (Hazard ratio: 0.402, 95% CI: 0.204-0.793, p = 0.009). CONCLUSION: In this study surgical resection beyond 4 weeks after presentation seems to have a better short- and long-term outcome for LSOCC.

Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design.

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .

Bariatric Surgery for Monogenic Non-syndromic and Syndromic Obesity Disorders.

PURPOSE OF REVIEW: The global prevalence of obesity has increased rapidly over the last decades, posing a severe threat to human health. Currently, bariatric surgery is the most effective therapy for patients with morbid obesity. It is unknown whether this treatment is also suitable for patients with obesity due to a confirmed genetic defect (genetic obesity disorders). Therefore, this review aims to elucidate the role of bariatric surgery in the treatment of genetic obesity. RECENT FINDINGS: In monogenic non-syndromic obesity, an underlying genetic defect seems to be the most important factor determining the efficacy of bariatric surgery. In syndromic obesity, bariatric surgery result data are scarce, and even though some promising follow-up results have been reported, caution is required as patients with more severe behavioral and developmental disorders might have poorer outcomes. There is limited evidence in support of bariatric surgery as a treatment option for genetic obesity disorders; hence, no strong statements can be made regarding the efficacy and safety of these procedures for these patients. However, considering that patients with genetic obesity often present with life-threatening obesity-related comorbidities, we believe that bariatric surgery could be considered a last-resort treatment option in selected patients.

Measuring quality of life in bariatric surgery: a multicentre study.

BACKGROUND: Current studies mainly focus on total weight loss and comorbidity reduction. Only a few studies compare Quality of Life (QoL) after sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). This study was conducted to examine the extent of improvement in QoL on different domains after primary bariatric surgery and compare these results to Dutch reference values. METHODS: The study included prospectively collected data from patients who underwent primary bariatric surgery in five Dutch hospitals. The RAND-36 questionnaire was used to measure the patient's QoL; preoperatively and twelve months postoperatively. Postoperative scores were compared to Dutch reference values, standardized for age, using t-test. A difference of more than 5% was considered a minimal important difference. A multivariate linear regression analysis was used to compare SG and RYGB on the extent of improvement, adjusted for case-mix factors. RESULTS: In total, 4864 patients completed both the pre- and postoperative questionnaire. Compared with Dutch reference values, patients postoperatively reported clinically relevant better physical functioning (RYGB + 6.8%), physical role limitations (SG + 5.6%; RYGB + 6.2%) and health change (SG + 77.1%; RYGB + 80.0%), but worse general health perception (SG - 22.8%; RYGB - 17.0%). Improvement in QoL was similar between SG and RYGB, except for physical functioning (ß 2.758; p-value 0.008) and general health perception (ß 2.607; p-value < 0.001) for which RYGB patients improved more. CONCLUSIONS: SG and RYGB patients achieved a better postoperative score in physical functioning, physical role limitations and health change compared to Dutch reference values, and a worse score in general health perception.

Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.

BACKGROUND: Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing SG and RYGB has been performed in adolescents. OBJECTIVE: Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity. METHODS: A multicenter randomized controlled non-inferiority trial. Two hundred sixty-four adolescents aged 13-17 (Tanner stage ≥IV) with severe obesity (corrected for age and sex) will be included. Adolescents agreeing to participate will be randomized to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at 3 years postoperatively. Secondary outcomes include (i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition. Follow-up will extend into the long term. RESULTS: Not applicable. DISCUSSION: This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020).

Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

OBJECTIVE: To define "best possible" outcomes for bariatric surgery (BS)(Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG]). BACKGROUND: Reference values for optimal surgical outcomes in well-defined low-risk bariatric patients have not been established so far. Consequently, outcome comparison across centers and over time is impeded by heterogeneity in case-mix. METHODS: Out of 39,424 elective BS performed in 19 high-volume academic centers from 3 continents between June 2012 and May 2017, we identified 4120 RYGB and 1457 SG low-risk cases defined by absence of previous abdominal surgery, concomitant procedures, diabetes mellitus, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, anticoagulation, BMI>50 kg/m and age>65 years. We chose clinically relevant endpoints covering the intra- and postoperative course. Complications were graded by severity using the comprehensive complication index. Benchmark values were defined as the 75th percentile of the participating centers' median values for respective quality indicators. RESULTS: Patients were mainly females (78%), aged 38±11 years, with a baseline BMI 40.8 ±â€Š5.8 kg/m. Over 90 days, 7.2% of RYGB and 6.2% of SG patients presented at least 1 complication and no patients died (mortality in nonbenchmark cases: 0.06%). The most frequent reasons for readmission after 90-days following both procedures were symptomatic cholelithiasis and abdominal pain of unknown origin. Benchmark values for both RYGB and SG at 90-days postoperatively were 5.5% Clavien-Dindo grade ≥IIIa complication rate, 5.5% readmission rate, and comprehensive complication index ≤33.73 in the subgroup of patients presenting at least 1 grade ≥II complication. CONCLUSION: Benchmark cutoffs targeting perioperative outcomes in BS offer a new tool in surgical quality-metrics and may be implemented in quality-improvement cycle.ClinicalTrials.gov Identifier NCT03440138.

Outcome for Patients With Pathological Esophageal Acid Exposure After Laparoscopic Fundoplication.

OBJECTIVE: The aim of the current study was to assess symptomatic outcome and need for surgical reintervention for patients identified with pathological esophageal acid exposure by routine postoperative 24-hour pH-monitoring. BACKGROUND: Although laparoscopic fundoplication is associated with excellent short- and midterm results, recurrent symptoms pose an important challenge. Postoperative pH-monitoring is considered the "gold standard" for diagnosing recurrent GERD and frequently used for routine postoperative follow up. METHODS: Analysis of prospectively collected data from patients who underwent laparoscopic fundoplication between April 1994 and June 2015 and underwent routine postoperative 24-hour pH-monitoring was performed. Symptomatic outcome and need for surgical reintervention up to 5 years was compared between patients with pathological and physiological postoperative esophageal acid exposure. Primary endpoints were heartburn score and need for surgical reintervention for recurrent reflux. RESULTS: A total of 309 patients in whom routine postoperative 24-hour pH-monitoring was performed were included. Pathological acid exposure was present in 33 patients (11%) compared with 276 patients (89%) with physiological acid exposure. During 5-year follow up, there were no differences in heartburn, dysphagia, or satisfaction scores. Eighteen percent of all patients with abnormal postoperative pH-studies underwent redo fundoplication during 5-year follow up. CONCLUSIONS: Pathological acid exposure demonstrated by routine postoperative pH-monitoring was not associated with worse symptomatic outcome in terms of reflux control and satisfaction. A possible explanation for this finding is that laparoscopic fundoplication reduces the patients' ability to perceive reflux. This underlines the importance of assessing the association between symptomatic outcome and esophageal function tests in determining outcome of antireflux surgery.

Randomized clinical trial comparing laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh.

BACKGROUND: Current literature is characterized by a discrepancy between reported symptomatic and radiological recurrent hiatal hernia's following primary repair. Crural augmentation using mesh is suggested to reduce recurrence rates. The aim of this trial is to analyze 1-year outcome of laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh. METHODS: Between 2013 and 2016, 72 patients with an objectified hiatal hernia were randomized for primary repair using non-absorbable sutures and sutures reinforced with non-absorbable mesh. Data regarding the incidence of recurrent hiatal hernia, need for endoscopic dilatation or surgical reintervention, postoperative dysphagia and/or reflux symptoms, general health, and use of acid-suppressing medication were analyzed. RESULTS: 72 patients (n = 36 vs. n = 36) were included. One year after primary repair and repair using non-absorbable mesh, there were no differences in the number of recurrent hiatal hernia's demonstrated by barium swallow radiology (n = 4 [11.4%] vs. n = 6 [19.4%], p = 0.370) or upper gastrointestinal endoscopy (n = 5 [14.4%] vs. n = 5 [17.2%], p = 0.746), the number of surgical reinterventions (n = 2 [5.6%] vs. n = 1 [2.8%], p = 1.000), nor in chest pain and heartburn scores, with comparable dysphagia and satisfaction scores. Compared to the preoperative state, both groups demonstrated a comparable and significant reduction in chest pain score and Dakkak dysphagia score. CONCLUSIONS: Use of non-absorbable mesh to reinforce primary hiatal hernia repair results in equal hiatal hernia recurrence and symptomatic outcome compared to repair using sutures alone. During 1-year follow-up, there were no mesh-related complications. Follow-up beyond 1 year needs to demonstrate whether these findings are sustained.

Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and Conventional Nissen Fundoplication: A Plea for Patient Counseling and Clarification.

OBJECTIVE: To analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD). BACKGROUND: LNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling. METHODS: Between 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported. RESULTS: A total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047). CONCLUSIONS: The effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.

Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial.

BACKGROUND: Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery. METHODS: The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program. DISCUSSION: This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies. TRIAL REGISTRATION: Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

Equal patient satisfaction, quality of life and objective recurrence rate after laparoscopic hiatal hernia repair with and without mesh.

INTRODUCTION: Laparoscopic hiatal hernia repair has become standard practice for most surgeons performing antireflux surgery. Hiatal hernia repair consists of cruroplasty with sutures only or additional reinforcement using mesh. Use of mesh was initiated to reduce recurrence rates. Recent analyses show that use of mesh may influence radiologic recurrence rates, but it does not seem to prevent symptomatic recurrences and the need for reoperation. This study compares clinical and radiologic outcomes of primary cruroplasty and cruroplasty with non-absorbable mesh after laparoscopic hiatal hernia repair. METHODS: Retrospective analysis of prospectively followed cohort of patients undergoing laparoscopic correction of hiatal hernia type II-IV in two tertiary referral centers was carried out. Radiologic recurrence, symptomatic recurrence, reoperation rate, complications and patient-reported outcome measures were analyzed for all patients. RESULTS: A total of 189 patients were analyzed after laparoscopic hiatal hernia correction with an additional fundoplication [127 (67.2%) primary correction, 62 (32.8%) with mesh reinforcement]. After a mean follow-up of 39.3 months, the overall radiologic recurrence rate was 24.3%, which was equal in both groups [25.8% (mesh) vs 23.6% (no mesh), P = 0.331]. Symptomatic recurrence rate was 13.2% (16.1 vs 11.8%, P = 0.495) and reoperation rate 7.4% (9.7 vs 6.3%), which was comparable between the two groups. Complication rates were equal, and no serious mesh-related complications were reported. Health-related quality of life improved after surgery, dysphagia decreased and patient satisfaction was high for both groups without significant differences. CONCLUSION: Radiologic recurrences, symptomatic recurrences and reoperation rates are equal after laparoscopic hiatal hernia repair with or without non-absorbable mesh reinforcement, irrespective of hernia size and type. Quality of life, dysphagia and patient satisfaction were comparable. No serious mesh-related complications occurred. The results of this study do not support the routine use of mesh in hiatal hernia repair.