The Sleeve versus Bypass trial

Rationale: Morbid obesity has become one of the most frequent chronic disorders in Western countries, affecting 1.5-2% of the Dutch population. Currently, as the laparoscopic banding procedure is declining in popularity due to its poor percentage Extra Weight Loss (%EWL) results and its high rate of late serious complications, the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) seems to be one of the best options as a treatment for morbid obesity. However, the higher risk of dumping syndrome makes it a potentially less attractive option due to its negative effects on the quality of life. Laparoscopic Sleeve Gastrectomy (LSG) is a new promising bariatric procedure which has the theoretical advantages of keeping the gastrointestinal tract intact, making it possible to perform endoscopic therapy (gastroscopy, ERCP) after LSG. Because there is no bypass of the jejunum there is theoretically a smaller chance of vitamin deficits and a better QOL. LSG is further an easier and faster procedure. Short term prospective small patient-studies show equal %EWL of both techniques, however long-term results on %EWL of the LSG are not available. The aim of the research proposal, a randomised long-term (5-year FU) comparing LSG with LRYGB, is to clarify this question and analyse the impact on quality-of-life (QOL) of these patient-groups. As certain subgroups (type 2 Diabetes Mellitus (DM-2); BMI >50; sweet eaters; Gastro Esophagal Reflux Disease (GERD)) can have different outcomes compared to those who do not belong to such subgroups, this study explictly takes subgroup analysis into account.

"Objective:
The primary objective is to evaluate if %EWL after LSG as bariatric therapy is equal or, within an acceptable margin, inferior to LRYGB.
Secondary objectives are to evaluate QOL, cure /improvement of obesity related co-morbidity (i.e. DM-2, hypertension, hypercholesterolemia, Obstructive Sleep Apnoea Syndrome (OSAS), GERD, weight induced joint pain), complications, readmission rate, re-operation rate, revisive surgery (Re-do) rate, return to work rate. Furthermore, this study evaluates if combining the bariatric procedure with a cholecystectomy in morbidly obese patients with gallbladder stones is to be advocated. Moreover, technical aspects of the LSG and the LRYGB like OR time, blood loss, technical complications and difficulties will be evaluated"

Study design: A randomized, open label, multicenter non-inferiority trial comparing bariatric treatment of morbid obesity by either LSG or LRYGB.

All patients are treated in a fast-track protocol and discharged one day after surgery. Antithrombotic prophylaxes (Fragmin® 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both treatments in this study are performed on regular basis as a stand-alone therapy for morbid obesity in the Netherlands and abroad, with rising rates of LSG and LRYGB. The place of the LSG as a stand-alone therapy is unknown as long-term results are currently lacking. However, short term results are promising and two short term prospective randomized small-size patient-studies show equal results in terms of %EWL (17,18). The only difference compared to standard LRYGB treatment is that patients have to fill out three QOL-questionnaires on admission and after 3,6,12, 24, 36, 48, 60 months and have to undergo an additional gallbladder ultrasound investigation prior to surgery. The additional burden for study participants is considered to be minimal.