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Background Approximately 8–15% of patients undergoing bariatric surgery develop symptomatic gallstone disease within 24 months after surgery. Ursodeoxycholic acid (UDCA) seems to effectively prevent the formation of gallstones detectable by ultrasound after bariatric surgery. The aim of the UPGRADE trial is to provide evidence on the prophylactic use of UDCA in preventing symptomatic gallstone disease postoperatively. Methods The UPGRADE trial is designed as a randomised, placebo-controlled, double-blind multicentre trial in patients with morbid obesity undergoing Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Patients are randomly assigned to either UDCA 900 mg daily for 6 months or placebo treatment. This paper details the statistical analysis plan (SAP) of this trial and was submitted before outcome data were available. Results The primary endpoint of this trial is symptomatic gallstone disease within 24 months after bariatric surgery, defined as admission or hospital visit for symptomatic gallstone disease. Secondary outcomes consist of the development of gallstones/sludge on ultrasound at 24 months in the gallstone-negative group at baseline, presence of gallstones/sludge on ultrasound at 24 months, number of cholecystectomies, side effects of UDCA, therapy compliance, quality of life, costs and revenues. Analyses will be completed according to this pre-specified SAP. The main analysis will be performed as a standard ITT analysis using the chi-squared test. Discussion The UPGRADE trial will show if prophylactic use of UDCA reduces the incidence of symptomatic gallstone disease after bariatric surgery. Unforeseen deviations from the SAP at the time of analysis will be motivated and discussed. Trial registration The Netherlands Trial Register NL5954 . Registered on 21 November 2016.

Background The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. Methods A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. Discussion The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. Trial registration Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

Purpose Patients who undergo bariatric surgery are at risk for developing cholesterol gallstones. We aimed to identify risk factors that are associated with symptomatic gallstone disease and gallstone formation after bariatric surgery. Materials and Methods We included participants of the UPGRADE trial, a multicenter randomized placebo-controlled trial on the prevention of symptomatic gallstone disease with ursodeoxycholic acid (UDCA) after bariatric surgery. The association between patient characteristics and symptomatic gallstone disease, and gallstone formation was evaluated using logistic regression analysis. Results Of 959 patients, 78 (8%) developed symptomatic gallstone disease within 24 months. Risk factors were the presence of a pain syndrome (OR 2.07; 95% CI 1.03 to 4.17) and asymptomatic gallstones before surgery (OR 3.15; 95% CI 1.87 to 5.33). Advanced age (OR 0.95; 95% CI 0.93 to 0.97) was protective, and UDCA prophylaxis did not reach statistical significance (OR 0.64; 95% CI 0.39 to 1.03). No risk factors were identified for gallstone formation, whereas advanced age (OR 0.98; 95% CI 0.96 to 1.00), statin use (OR 0.42; 95% CI 0.20 to 0.90), and UDCA prophylaxis (OR 0.47; 95% CI 0.30 to 0.73) all reduced the risk. Conclusion Young patients with a preoperative pain syndrome and/or asymptomatic gallstones before bariatric surgery are at increased risk for symptomatic gallstone disease after surgery. Whether statins, either alone or in combination with UDCA prophylaxis, can further reduce the burden of gallstones after bariatric surgery should be investigated prospectively. Graphical abstract

BackgroundSeveral studies have shown a reduction in postoperative pain and length of hospital stay when using intraperitoneal local anesthetics during laparoscopic surgery. In morbidly obese patients, respiratory depression due to opioid use is a serious side effect. Any different type of analgesia is therefore clinically relevant.ObjectiveTo assess the effect of intraperitoneal bupivacaine on postoperative pain after laparoscopic Roux-en-Y gastric bypass (LRYGB).MethodsBetween March and November 2017, 130 patients were included and randomly assigned to receive 20 ml or 0 ml of 2.5% bupivacaine hydrochloride sprayed onto the diaphragm. Pain scores for abdominal and shoulder pain were conducted using the visual analogue scale (VAS) for pain score at 0, 1, 6, and 24 h postoperatively. The length of hospital stay and use of analgesics was recorded in digital patient records. The primary outcome is the pain scores and the secondary outcomes are postoperative use of opioids or antiemetics and length of hospital stay.ResultsThe study and control group contained respectively 66 and 61 patients. Patient characteristics were equal in both groups (p < 0.05), except for age. No significant reduction of postoperative pain or opioid use was seen with the use of intraperitoneal bupivacaine. There was also no significant reduction in the use of antiemetics and length of hospital stay.ConclusionThe use of intraperitoneal bupivacaine in LRYGB does not show a statistically significant reduction in postoperative pain or postoperative opioid use. Therefore, using intraperitoneal bupivacaine has no clinical relevance and should no longer be used in LRYGB.

Background An emerging and promising minimally invasive treatment for pilonidal disease (PD) is sinus laser-assisted closure (SiLaC®). Previous studies have shown encouraging results concerning safety, patient satisfaction, wound healing and acceptable recurrence rates. This study investigated outcomes for a large cohort of PD patients treated with SiLaC®. Methods A multicentre cohort study with a prospective design and partial retrospective data collection for patients with PD treated with SiLaC® in three hospitals in the Netherlands (Albert Schweitzer Hospital, Flevoziekenhuis and Medical Centre Zuiderzee) from January 1st 2017 to March 1st 2020. The primary outcome was recurrence. Secondary outcomes were incidence of complete wound closure, time until wound closure, postoperative complications, ability to perform daily activities and reported patient satisfaction. Results A total of 311 patients were included with a median follow-up of 10 months (range 1–52 months). The recurrence rate after one SiLaC® treatment was 26% with 7% experiencing incomplete wound closure, resulting in an initial success rate of 66% after one SiLaC® procedure. This increased to 92% and 98% after two and three SiLaC® procedures, respectively. Mean time until wound closure was 6 weeks (range 1–24 weeks). Seven patients (2%) were still unsuccessfully treated after three SiLaC® treatments and required additional and extensive surgery. Mean time to perform regular daily activities including working was 6 days (range 0–42 days) and the vast majority of patients (84%) did not require painkillers or only paracetamol. Twelve patients (4%) developed a postoperative wound infection. The mean satisfaction score was 9 (range 5–10). Conclusions SiLaC® is a promising minimally invasive treatment for PD with high patient satisfaction and an acceptable success rate. These results suggest that SiLaC® could be used as a safe and effective primary treatment for PD.

Purpose Patient-reported outcomes are important as obesity is a chronic disease with a substantial impact. A multidisciplinary task force selected six scales (48 questions) from the validated BODY-Q questionnaire. This subset was gradually introduced and evaluated in a mandatory nationwide registry. The focus was to assess the scale’s module results and its feasibility in a quality registry. Materials and Methods All Dutch patients undergoing bariatric surgery between 2019 and 2022 were selected. Completed questionnaires of RAND-36, EQ-5D-5L, and BODY-Q were reviewed with baseline and 1-year results. Uni- and multivariable regression analyses were performed to assess the relationship between baseline characteristics and quality of life scores over time. Results A total of 10,972 patients completed at least one BODY-Q scale. The lowest score was on the body image scale preoperatively (28.2, SD 20.9) and the highest on the social scale postoperatively (76.2, SD 18.8). A representative group of 510 patients with repeated measurements showed the most improvement on the body image scale (+ 32.2) followed by physical function (+ 26.3). Multivariable linear regression analysis showed a significant influence, primarily for gender, age, and BMI on BODY-Q scores. Score improvement for BODY-Q was mainly driven by weight loss, while EQ-5D-5L and RAND-36 showed no clear pattern. Comparing the three questionnaires showed significant correlations for physical and social function only. Conclusion The BODY-Q obesity module demonstrates potential as a relevant PROM for inclusion in a quality registry. BODY-Q scores provide a foundation for future research, with notable improvements in quality of life observed, particularly in the body image and physical function scales. Graphical Abstract

Laparoscopic adjustable gastric banding (LAGB) and vertical-banded gastroplasty (VBG) are surgical treatment modalities for morbid obesity. This prospective study describes the long-term results of LAGB and VBG. One hundred patients were included in the study. Fifty patients underwent LAGB and 50 patients, open VBG. Study parameters were weight loss, changes in obesity-related comorbidities, long-term complications, re-operations including conversions to other bariatric procedures and laboratory parameters including vitamin status. From 91 patients (91%), data were obtained with a mean follow-up duration of 84 months (7 years). Weight loss [percent excess weight loss (EWL)] was significantly more after VBG compared with LAGB, 66% versus 54%, respectively. All comorbidities significantly decreased in both groups. Long-term complications after VBG were mainly staple line disruption (54%) and incisional hernia (27%). After LAGB, the most frequent complications were pouch dilatation (21%) and anterior slippage (17%). Major re-operations after VBG were performed in 60% of patients. All re-operations following were conversions to Roux-en-Y gastric bypass (RYGB). In the LAGB group, 33% of patients had a refixation or replacement of the band, and 11% underwent conversion to another bariatric procedure. There were no significant differences in weight loss between patients with or without re-interventions. No vitamin deficiencies were present after 7 years, although supplement usage was inconsistent. This long-term follow-up study confirms the high occurrence of late complications after restrictive bariatric surgery. The failure rate of 65% after VBG is too high, and this procedure is not performed anymore in our institution. The re-operation rate after LAGB is decreasing as a result of new techniques and materials. Results of the re-operations are good with sustained weight loss and reduction in comorbidities. However, in order to achieve these results, a durable and complete follow-up after restrictive procedures is imperative.

Objective In order to increase weight loss and minimize complications, a preoperative diet before bariatric has been advocated. However, some diets are poorly tolerated by patients and this can lead to low compliance and too little weight loss. In this study, we aim to compare two preoperative diets in order to find the most suitable for this patient population. Methods Comparison of preoperative diets before bariatric surgery with a randomized non-inferiority trial in order to compare the standard very low calorie diet (VLCD) by protein shakes (Prodimed) with a standard diet using ordinary products. The primary outcome parameter was preoperative weight loss. Secondary outcome parameters were operation time, difficulty of surgery, short-term complications, short-term weight loss and compliance, tolerance, and acceptance of the diets. Results Two hundred twelve patients suitable for gastric bypass surgery were included and randomized. The Prodimed group contained 105 patients, the standard diet group 107 patients. Preoperative weight loss and 4 weeks after the procedure were not significantly different between the two diet groups. Operation time, difficulty of surgery, short-term complications, and short-term weight loss were also comparable without significant differences between the diet groups. However, most of the parameters measuring patients’ compliance, tolerance, and acceptance of the diets were significantly better in the standard diet group as compared to the patients in the Prodimed group. Conclusion Protein shakes and standard diets are capable of achieving good and comparable results on preoperative weight loss before bariatric surgery. However, patients’ compliance, tolerance, and acceptance were all significantly better after a standard diet. We recommend giving patients a choice in preoperative diets in order to achieve the best possible weight loss and results.

Vertical banded gastroplasty (VBG) is a widely used restrictive procedure in bariatric surgery. However, the re-operation rate after this operation is high. In the case of VBG failure, a conversion to Roux-en-Y gastric bypass (RYGBP) is an option. A study was undertaken to evaluate the results of the conversion from VBG to RYGBP. 101 patients had conversion from VBG to RYGBP. Patients were separated into 3 groups, based on the indication for conversion: weight regain (group 1), excessive weight loss (group 2) and severe eating difficulties (group 3). Data for the study were collected by retrospective analysis of prospectively recorded data. Weight regain (group 1) was the reason for conversion in 73.3% of patients. Staple-line disruption was the most important cause for the weight regain (74.3%). Excessive weight loss (group 2) affected 14% of patients and was caused by outlet stenosis in 78.6% of patients. The remaining 13% had severe eating difficulties as a result of outlet stenosis (46.1%), pouch dilatation (30.8%) and pouch diverticula (23.1%). Mean BMI before conversion to RYGBP was 40.5, 22.3 and 29.8 kg/m2 in group 1, 2 and 3, respectively. Minor or major direct postoperative complications were observed in 2.0% to 7.0%. Long-term complications were more frequent, and consisted mainly of anastomotic stenosis (22.7%) and incisional hernia (16.8%). Follow-up after conversion was achieved in all patients (100%), with a mean period of 38 +/- 29 months. BMI decreased from 40.5 to 30.1 kg/m2, increased from 22.3 to 25.3 kg/m2. and decreased slightly from 29.8 to 29.0 kg/m2 in group 1, 2 and 3, respectively. All patients in group 3 noticed an improvement in eating difficulties. Complications after conversion from failed VBG to RYGBP are substantial and need to be considered. However, the conversion itself is a successful operation in terms of effect on body weight and treating eating difficulties after VBG.

Quality of life improves after bariatric surgery. However, long-term results and the influence of reoperations are not well known. A prospective quality of life assessment before, 1 and 7 years after laparoscopic adjustable gastric banding (LAGB) and vertical banded gastroplasty (VBG) was performed in order to determine the influence of reoperations during follow-up. One hundred patients were included in the study. Fifty patients underwent VBG and 50 LAGB. Patients completed the quality of life questionnaires prior to surgery and two times during follow-up. Health-related quality of life (HRQoL) questionnaires included the Nottingham Health Profile I and II and the Sickness Impact Profile 68. Follow-up was 84% with a mean duration of 84 months (7 years). During follow-up, 65% of VBG patients underwent conversion to Roux-en-Y gastric bypass while 44% of LAGB patients underwent a reoperation or conversion. One year after the procedure, nearly all quality-of-life parameters significantly improved. After 7 years, the Nottingham Health Profile (NHP)-I domain “physical ability”, the NHP-II and the SIP-68 domains “mobility control”, “social behavior”, and “mobility range” were still significantly improved in both groups. The domains “emotional reaction”, “social isolation” (NHP-I), and “emotional stability” (SIP-68) remained significantly improved in the VBG group while this was true for the domain “energy level” (NHP-I) in the LAGB group. Both the type of procedure and reoperations during follow-up were not of significant influence on the HRQoL results. Weight loss and decrease in comorbidities were the only significant factors influencing quality of life. Restrictive bariatric surgery improves quality of life. Although results are most impressive 1 year after surgery, the improvement remains significant after long-term follow-up. Postoperative quality of life is mainly dependent on weight loss and decrease in comorbidities and not on the type of procedure or surgical complications.