|- candidate number||19305|
|- NTR Number||NTR4741|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-aug-2014|
|- Secondary IDs||NL37501.101.11 CCMO nummer|
|- Public Title||The Sleeve versus Bypass trial |
|- Scientific Title||Laparoscopic Sleeve Gastrectomy versus laparoscopic Roux-en-Y Gastric bypass trial for Morbid Obesity.|
|- hypothesis||Our hypothesis is that LSG has a comparable %EWL after 5 years when compared to LRYGB [18-22]. Even if LSG is marginally less effective compared to LRYGB in terms of long term %EWL, QOL might be better from a dietary and long term complications point of view |
|- Healt Condition(s) or Problem(s) studied||Bariatric surgery, Obesity, Morbid obesity |
|- Inclusion criteria||All morbidly obese patients who have been approved for bariatric surgery by the preoperative multidisciplinary team can be included in the sleeve versus bypass trial. Informed consent is mandatory. The criteria for bariatric surgery are age 18-60 years , BMI> 40, or > 35 kg/m2 with obesity-related-comorbidity (such as type 2 diabetes, hypertension, hypercholesterolemia, severe arthrosis and OSAS) for more than 3 years, conservative therapy (preferably under the guidance of a physician or self-help group) that has failed or showed only transient results, completion of psychological screening, excluding patients with psychiatric and psychological disorders, written informed consent and willingness to conclude the lifelong follow up program after surgery. |
|- Exclusion criteria||Exclusion criteria for this study are: diagnosed gastro oesophageal reflux disease (GERD) , severe sweet eating  prior bariatric surgery, prior major abdominal surgery (such as colonic resection, abdominal sepsis, aortic surgery, which might jeopardise the technical feasibility of LSG or LRYGB) and the inability of reading or understanding the questionnaires.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||1-nov-2015|
|- Target number of participants||620|
|- Interventions||All patients are treated in a fast-track protocol and discharged one day after surgery. Antithrombotic prophylaxes (FragminŽ 5000 u/day) and a fluid diet is continued for two weeks postoperatively. All patients are prescribed proton pump inhibitors for 6 weeks after surgery. |
All participating surgeons are experienced bariatric surgeons that have performed at least 150 LSG and 150 LRYGB and work in bariatric centres of excellence that perform over 500 cases per year.
Laparoscopic Sleeve Gastrectomy or a Laparoscopic Roux en Y Gastric Bypass is performed.
|- Primary outcome||Primary endpoint: |
Sustainable weight loss. The amount of weight loss is expressed as percentage excess weight loss (%EWL), and calculated with the formula %EWL = (pre-operative weight ¨C current weight) / (pre-operative weight- ideal weight) X 100%. For this formula a BMI of 25 kg/m2 was taken as the upper limit of normal, i.e. the ideal weight.
|- Secondary outcome||To evaluate operating time, duration of hospital stay, intra-operative and post-operative in-hospital mortality and morbidity following LSG or LRYGB. Morbidity is defined as re-operations, re-interventions, re-admissions and serious adverse events. Morbidity is also defined as major (anastomotic leakage, major per-operative blood loss due to splenic or vascular haemorrhage, pulmonary embolism, intra-abdominal abscess and intra-abdominal hematoma) or minor (wound infection, urinary tract infection and anastomotic stenosis). Moreover, the rate of extra outpatient and emergency room visits because of complaints following LSG or LRYGB are evaluated.|
To evaluate QOL questionnaires are used objectified by the asthma control questionnaire (ACQ), the reflux disease questionnaire (Gerd-Q), the Bariatric Analysis and Reporting Outcome System (BAROS) score, the Gastro-intestinal Quality of life Index (GIQLI), EuroQol-5D (EQ-5D) , Short-form 36 (SF-36) before and following LSG or LRYGB.
To evaluate the predictive value of the Sweet eating inventoried by the Dutch Sweet Eating Questionnaire (DSEQ).
To evaluate the need for revision surgery (need to perform an additional bariatric procedure after the performed surgery) as a result of insufficient weight loss or medical complaints within 5 years following the primary bariatric procedure (LSG or LRYGB).
To evaluate the biochemical changes following LRYGB or LSG. In the first year extended blood tests are obtained every 3 months. This is continued in the yearly visits which are common practice in our clinics.
|- Timepoints||8 weeks, 3 months, 6 months, 1 year, then annualy till 5 years |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD L.U. Biter|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E. Birnie|
|- Sponsor/Initiator ||Sint Franciscus Gasthuis (SFG) |
(Source(s) of Monetary or Material Support)
|- Brief summary||Background |
Obesity is an increasing disease worldwide. Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients. Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold standard surgical technique. Laparoscopic Sleeve Gastrectomy (LSG) is a new promising bariatric procedure which has the advantage of maintaining an intact gastrointestinal tract . The aim of this study is to evaluate the efficiency of both techniques. Our hypothesis is that LSG has a similar %EWL after 5 years compared to LRYGB.
The Sleeve Bypass Trial is a randomized multicentre clinical trial: patients eligible for bariatric surgery are randomized to either LSG or LRYGB. Patients with a body mass index (BMI) > 40 kg/m2 or BMI 35 kg/m2 with obesity related comorbidity (diabetes type 2, sleep apnoea, hypertension) are eligible for randomization. At randomization patients are stratified for centre, sex, diabetes type 2 and BMI > 50 kg/m2. A total number of 620 patients will be enrolled and equally (1:1) randomized to both treatment arms. Only surgeons experienced in both operation techniques will participate in the Sleeve Bypass trial. The primary endpoint is the 5-year Percentage Excess Weight Loss (%EWL) of LSG and LRYGB. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life.
Long-term %EWL between the two treatment strategies used to be in favour of LRYGB, but more recent results throughout the world show similar %EWL in both techniques. If weight loss is comparable, obesity-related comorbidity and QOL after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future.
|- Main changes (audit trail)|
|- RECORD||16-aug-2014 - 6-sep-2014|