Cost-effectiveness of ursodeoxycholic acid in preventing new-onset symptomatic gallstone disease after Roux-en-Y gastric bypass surgery.

BACKGROUND: The aim was to evaluate the cost-effectiveness and cost-utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery. METHODS: Data from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900 mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY). RESULTS: Patients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were -€356 (95 per cent Bca c.i. €-1573 to 761) from a healthcare perspective and -€1392 (-3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872. CONCLUSION: UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.

Factors associated with adherence to ursodeoxycholic acid or placebo in patients after bariatric surgery.

BACKGROUND: Ursodeoxycholic acid (UDCA) reduces symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB). The beneficial effect of UDCA is reduced by poor adherence. OBJECTIVES: We aimed to identify factors associated with poor adherence to UDCA or placebo after bariatric surgery. SETTING: Outpatient clinic and department for bariatric surgery in three hospitals in the Netherlands. METHODS: Patients in the multicenter, double-blind, randomized, placebo-controlled UPGRADE trial were assessed for adherence to 900 mg UDCA or placebo for 6 months through a pill count, inquiries during follow-up, and a questionnaire. Poor adherence was defined as the usage of <300 of 364 pills within a maximum of 8 months postoperatively. Multivariable logistic regression analysis was used to identify factors contributing to poor adherence. RESULTS: In total, 967 patients were included (mean age [standard deviation (SD)]: 45.1 [11.1] years; female: 772 [80%]; RYGB: 889 [92%]; sleeve gastrectomy: 78 [8%]), of whom 357 (37%) were poor adherers. Factors associated with poor adherence were age (OR .97; 95% confidence interval [CI] .96-.98, a decrease in age increases the odds for poor adherence), foreign origin (odds ratio [OR] 2.07; 95%CI 1.50-2.84), unemployment (OR 1.73; 95%CI 1.28-2.34), and sleeve gastrectomy (OR 1.79; 95%CI 1.06-3.01). Furthermore, a difference in adherence status was also noted for the centers of surgery. CONCLUSIONS: The adherence rate to UDCA and placebo in the UPGRADE trial was suboptimal. Several factors were independently associated with poor adherence. Our findings can help to identify patients who may benefit from extra guidance to improve adherence.

Risk Factors for Symptomatic Gallstone Disease and Gallstone Formation After Bariatric Surgery.

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.

Sinus laser-assisted closure (SiLaC®) for pilonidal disease: results of a multicentre cohort study.

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.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial.

BACKGROUND: Rapid weight loss is a major risk factor for the formation of cholesterol gallstones. Consequently, patients with morbid obesity undergoing bariatric surgery frequently develop symptomatic gallstone disease. This trial assessed the efficacy of ursodeoxycholic acid versus placebo for the prevention of symptomatic gallstone disease after bariatric surgery. METHODS: This multicentre, double-blind, randomised, placebo-controlled superiority trial enrolled patients with an intact gallbladder scheduled for laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy in three hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module to receive 900 mg ursodeoxycholic acid daily for 6 months or matched placebo. Randomisation was stratified by the presence of asymptomatic gallstones at baseline and type of surgery. Patients, clinicians, and study staff were masked to treatment allocation. The primary endpoint was symptomatic gallstone disease within 24 months, assessed in the modified intention-to-treat population (all randomly assigned eligible patients with any post-randomisation measurement). Prespecified subgroup analyses were done based on the stratification groups. Safety was assessed in all patients who took at least one dose of the study drug. This trial is registered with the Netherlands Trial Register, NL5954. FINDINGS: Between Jan 11, 2017, and Oct 22, 2018, 985 patients were randomly assigned to receive either ursodeoxycholic acid (n=492) or placebo (n=493). 967 patients were included in the modified intention-to-treat population, of whom 959 had data available for primary endpoint assessment. 189 (20%) patients had asymptomatic gallstones at baseline and 78 (8%) received a sleeve gastrectomy. Symptomatic gallstone disease occurred in 31 (6·5%) of 475 patients in the ursodeoxycholic acid group and in 47 (9·7%) of 484 patients in the placebo group (relative risk 0·67, 95% CI 0·43-1·04, p=0·071). Logistic regression showed a significant interaction between ursodeoxycholic acid and the presence of asymptomatic gallstones at baseline (p=0·046), with an effect of ursodeoxycholic acid in patients without (0·47, 0·27-0·84, p=0·0081), and no effect in patients with asymptomatic gallstones at baseline (1·22, 0·61-2·47, p=0·57). The effect was stronger in patients without gallstones at baseline undergoing RYGB (0·37, 0·20-0·71, p=0·0016), whereas the subgroup of patients undergoing sleeve gastrectomy was too small to draw clear conclusions. Adverse events were rare. In the ursodeoxycholic acid group, diarrhoea occurred in four (0·9%) of 444 patients and skin rash in two (0·5%) patients. In the placebo group, diarrhoea occurred in two (0·4%) of 453 patients and skin rash in two (0·4%) patients. The total number of serious adverse events did not significantly differ between the trial groups (75 [17%] in 444 patients in the ursodeoxycholic acid group and 102 [23%] in 453 patients in the placebo group). The most common serious adverse events were abdominal pain and internal hernia. No serious adverse event was attributed to the study drug. INTERPRETATION: Ursodeoxycholic acid prophylaxis did not significantly reduce the occurrence of symptomatic gallstone disease in all patients after bariatric surgery. In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease compared with placebo. Further research is needed to assess the efficacy of ursodeoxycholic acid after sleeve gastrectomy. FUNDING: The Netherlands Organization for Health Research and Development, Zambon Netherlands BV, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial).

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.

The Use of Intraperitoneal Bupivacaine in Laparoscopic Roux-en-Y Gastric Bypass: a Double-blind, Randomized Controlled Trial.

BACKGROUND: Several 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. OBJECTIVE: To assess the effect of intraperitoneal bupivacaine on postoperative pain after laparoscopic Roux-en-Y gastric bypass (LRYGB). METHODS: Between 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. RESULTS: The 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. CONCLUSION: The 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.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).

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.

Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized, Single-Blinded, Non-inferiority Trial.

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.

Is there a relation between number of adjustments and results after gastric banding?

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a standard restrictive bariatric procedure. Previous studies have shown that patients lost to follow-up do worse than patients who remain in follow-up. However, it is unknown if this is purely because of a lack of band adjustments. The aim of this study was to study the relation between number of adjustments and results. METHODS: Patients who underwent primary LAGB from October 2006 until March 2009 were included. The following parameters were collected: demographic characteristics, preoperative and postoperative weight, preoperative and postoperative status of co-morbidities, type of band, short- and long-term complications, reoperations, date, number and volume of adjustments, total amount of inserted volume, and last measured volume. RESULTS: One hundred seventy-four patients underwent primary LAGB. Twelve patients did not attend follow-up visits after 24 months (8.1%). Mean follow-up was 46 months, and excess weight loss, 47%. Eleven patients (8.1%) developed long-term complications, and 12 patients (8.8%) underwent revisional surgery. Patients underwent a mean number of 5 adjustments with a range of 0 to 18. The mean volume of totally inserted milliliters was 8 mL, with a range of 0 to 14 mL. There was a strong positive relation between number of adjustments and weight loss as well as reduction in obesity-related co-morbidities (r = .22; P<.01). There was no significant relation between number of adjustments and complications or revisional surgery. CONCLUSION: There is a strong relation between the number of band adjustments and weight loss, whereas complications and reoperations seem to be independent of the number of adjustments. A continual and lifelong follow-up of LAGB patients, including regular band volume adjustments, is necessary.

Salvage banding for failed Roux-en-Y gastric bypass.

BACKGROUND: After Roux-en-Y gastric bypass (RYGB), a substantial number of patients do not achieve successful long-term weight loss. In cases of loss of restriction, the application of an adjustable gastric band ("salvage banding") over the gastric pouch, or gastrojejunostomy, could prevent weight regain or increase weight loss. The objective of this literature review is to provide an overview of the studies that report the effect of salvage banding after failed RYGB. METHODS: A systemic literature search was conducted in PubMed, Google Scholar, Medline, the Cochrane Library, and the online websites of specific bariatric surgery journals to identify all relevant studies describing salvage banding after failed RYGB. RESULTS: Seven studies, with a total of 94 patients, were included for a systemic literature review. Inclusion criteria for salvage banding varied from unsuccessful weight loss to technical pouch failure. After salvage banding, all studies reported further weight loss, varying from 55.9%-94.2% excess body mass index loss (EBMIL) after 12-42 months of follow-up. In the included study group, 18% (17/94) of the patients developed long-term complications requiring a re-revision in 17% (16/94) of the cases. CONCLUSION: The results of all 9 studies that were included in this review report a further increase in weight loss after salvage banding for failed RYGB. In case of insufficient weight loss or technical pouch failure after RYGB, all reports suggest that salvage banding is a safe and feasible revisional procedure. Prospective studies are necessary to determine to the success of direct application of an adjustable gastric band in primary RYGB.

An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery.

Obesity (BMI 30-35 kg/m(2)) and its associated disorders such as type 2 diabetes, nonalcoholic fatty liver disease, and cardiovascular disease have reached pandemic proportions worldwide. For the morbidly obese population (BMI 35-50 kg/m(2)), bariatric surgery has proven to be the most effective treatment to achieve significant and sustained weight loss, with concomitant positive effects on the metabolic syndrome. However, only a minor percentage of eligible candidates are treated by means of bariatric surgery. In addition, the expanding obesity epidemic consists mostly of relatively less obese patients who are not (yet) eligible for bariatric surgery. Hence, less invasive techniques and devices are rapidly being developed. These novel entities mimic several aspects of bariatric surgery either by gastric restriction (gastric balloons, gastric plication), by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve stimulation), or by partial exclusion of the small intestine (duodenal-jejunal sleeve). In the last decade, several novel less invasive techniques have been introduced and some have been abandoned again. The aim of this paper is to discuss the safety, efficacy, complications, reversibility, and long-term results of these latest developments in the treatment of obesity.

Roux-en-Y gastric bypass as revisional procedure after gastric banding: leaving the band in place.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) are frequently used bariatric procedures. With both techniques, LAGB more than RYGB, failures occur. After years of experience with both techniques, we present a series of patients who underwent RYGB after failed LAGB. The band was kept in place. Our objective was to evaluate the safety and short-term effectiveness of RYGB after failed LAGB, without removing the band. The setting was a large teaching hospital in Heerlen, The Netherlands. METHODS: We first retrospectively considered the efficacy and complication rate of adding an adjustable band to RYGB. This was safe and effective. The patients lost a median of 7.6 kg within a median period of 21 months. The complication rate was low. Observing the positive results in this group, we began to leave the band in place when converting patients from LAGB to RYGB. RESULTS: A total of 12 patients underwent revision of LAGB to RYGB. There was no mortality. The complication rate and severity were low. During a median period of 16 months, the patients lost a median of 23 kg or 8 points in the body mass index. Also, additional improvement in co-morbidities was observed. CONCLUSION: Our results suggest that performing RYGB after LAGB and leaving the band in place is feasible, safe, and effective in the short term.

[EndoBarrier for counteracting obesity and metabolic syndrome]. / EndoBarrier tegen obesitas en het metabool syndroom.

The prevalence of obesity is increasing worldwide. Its primary treatment consists of lifestyle changes. In severely obese (BMI > 40 kg/m2 or ≥ 35 kg/m2 with comorbidity) patients though, bariatric surgery has been found to be the only way to achieve permanent weight loss. Operations such as the placement of a gastric band or a gastric bypass can, however, lead to complications and necessitate secondary interventions. In search of less invasive treatments, placement of the EndoBarrier duodenal jejunal bypass liner appears to be a promising, safe and effective method for facilitating weight loss. The EndoBarrier is a plastic flexible tube which is gastroscopically placed in the duodenal bulb, directly behind the pylorus. It extends from the duodenum to the proximal jejunum. Recent studies have demonstrated significant weight reduction in comparison to control-diet patients. Concomitant positive effects on cardiovascular risk factors including diabetes type 2 were observed. A multicentre trial is currently being executed in order to unravel the mechanism behind these effects.

Influence of reoperations on long-term quality of life after restrictive procedures: a prospective study.

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.

Long-term results of bariatric restrictive procedures: a prospective study.

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.

A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery.

BACKGROUND: The endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients. We report on the first European experience with this device. METHODS: A multicenter, randomized clinical trial was performed. Forty-one patients were included and 30 underwent sleeve implantation. Eleven patients served as a diet control group. All patients followed the same low-calorie diet during the study period. The purpose of the study was to determine the safety and efficacy of the device. RESULTS: Twenty-six devices were successfully implanted. In 4 patients, implantation could not be achieved. Four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1). The remaining patients all completed the study. Mean procedure time was 35 minutes (range: 12-102 minutes) for a successful implantation and 17 minutes (range: 5-99 minutes) for explantation. There were no procedure related adverse events. During the study period the 26 duodenal-jejunal bypass sleeve patients (100%) had at least one adverse event, mainly abdominal pain and nausea during the first week after implantation. Initial mean body mass index (BMI, kg/m2) was 48.9 and 47.4 kg/m2 for the device and control patients, respectively. Mean excess weight loss after 3 months was 19.0% for device patients versus 6.9% for control patients (P < 0.002). Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m2, respectively. Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period (lower glucose levels, HbA1c, and medication requirements). CONCLUSION: The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results. The device also has a significant positive effect on type 2 diabetes mellitus. Long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.This study was registered at www.clinicaltrials.gov (registration number: NCT00830440).

Conversion of vertical banded gastroplasty to Roux-en-Y gastric bypass results in restoration of the positive effect on weight loss and co-morbidities: evaluation of 101 patients.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.