RESUMO
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 percentage excess BMI loss (%EBMIL) after 5 years compared to LRYGB. METHODS/DESIGN: 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/m(2) or BMI 35 kg/m(2) with obesity related comorbidity (T2 DM, sleep apnoea, hypertension) are eligible for randomization. At randomization patients are stratified for centre, sex, T2 DM and BMI ≥ 50 kg/m(2). 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 weight loss (%EBMIL) of LSG and LRYGB. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life (QOL) defined in various questionnaires. DISCUSSION: Long-term %EBMIL between the two treatment strategies used to be in favour of LRYGB, but more recent results throughout the world show similar %EBMIL 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. TRIAL REGISTRATION: Dutch Trial Register: NTR 4741.
RESUMO
BACKGROUND: Morbid obesity has become one of the most frequent chronic medical disorders in Western countries, affecting 1.5-2 % of the Dutch population. Currently, the laparoscopic Roux-Y gastric bypass is considered to be the most effective bariatric treatment option for morbid obesity as it results in adequate weight loss and a significant decrease in comorbidity. Although this technique has been applied for years, the optimal lengths of the three bowel limbs (alimentary limb, biliopancreatic limb, and common channel) in order to achieve maximal percentage excess weight loss with minimal side effects (i.e. malabsorption symptoms), are unknown. As 'normal' sized gastric bypasses achieve an average of 60 - 80 % excess weight loss after one year, one could hypothesize that afferent limb lengths should be longer in order to reduce the common channel length, thereby improving outcome in terms of excess weight loss. The aim of the current study is to investigate the effect of the length of the common channel in gastric bypass surgery for morbid obesity. In this randomized controlled trial the very long Roux limb gastric bypass will be compared to the standard gastric bypass, in order to conclude which option is the optimal therapeutic strategy in the morbidly obese patient. METHODS/DESIGN: In this multicentre trial patients will be randomized either to a very long Roux limb gastric bypass with a fixed common channel length of 100 cm, or to a standard gastric bypass with a variable common channel length. The primary objective is to evaluate whether the very long Roux limb gastric bypass is superior in terms of percentage excess weight loss after one year follow-up compared to the standard gastric bypass. Secondary endpoints are quality-of-life, cure /improvement of obesity related comorbidity, complications, malnutrition, re-admission rate, and re-operation rate. DISCUSSION: We hypothesize that our proposed distal LRYGB will provide for improved results concerning % EWL with an acceptable rate of (metabolic) complications. Our main point of interest is to determine if the distal LRYGB is a superior alternative to standard LRYGB in terms of percentage excess weight loss and to put more focus on the role of the common channel. Therefore we will perform this randomized controlled trial comparing both techniques, with % EWL as a primary outcome. TRIAL REGISTRATION: CCMO registration number: NL43951.101.13 and Netherlands Trial Registry number: NTR4466.