BackgroundLaparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard in bariatric surgery, achieving durable long-term weight loss with improvement of obesity-related comorbidities. Lately, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity with similar results to LRYGB in terms of weight loss and comorbidity resolution. However, there is a lack of randomized controlled trials (RCT) comparing LMGB and LRYGB. This article describes the design and protocol of a randomized controlled trial comparing the outcomes of these two bariatric procedures.Methods/DesignThe trial is designed as a single center, randomized, patient and observer blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that LMGB is not inferior to LRYGB in terms of excess weight loss (EWL) the study is conducted as a non-inferiority trial with the sample-size calculations performed accordingly. EWL 12 months after surgery is the primary endpoint, whereas 3-year EWL, morbidity, mortality, remission of obesity related comorbidities, quality of life (QOL) and hormonal and lipid profile changes are secondary endpoints. Eighty patients, 18 years or older and with a body mass index (BMI) between 35 and 50 kg/m2 who meet the Swiss guidelines for the surgical treatment of morbid obesity will be randomized. The endpoints and baseline measurements will be assessed pre-surgery, peri-surgery and post-surgery (fixed follow up measurements are at discharge and at the time points 6 weeks and 12 and 36 months postoperatively).DiscussionWith its 3-year follow up time, this RCT will provide important data on the impact of LMGB and LRYGB on EWL, remission of comorbidities, QOL and hormonal and lipid profile changes.Trial registrationClinicalTrials.gov, NCT02601092. Registered on 28 September 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1957-9) contains supplementary material, which is available to authorized users.
Revisional laproscopic VVLL RYGB can be performed as a one-stage procedure by experienced bariatric surgeons but shows less effective EWL than primary RYGB procedures.
Purpose
A subset of patients undergoing Roux-en-Y gastric bypass (RYGB) presents with either insufficient weight loss or weight regain. Data on the revisional restrictive options including laparoscopic adjustable gastric band (LAGB) is scarce. This study analyzes the mid-term efficacy and safety of LAGB as a revisional procedure after RYGB.
Methods
Data of all patients with revisional LAGB after primary RYGB between January 2011 and May 2019 were retrospectively reviewed. Outcomes included assessment of weight changes, resolution of comorbidities, and early and late complications during the study period.
Results
Twenty patients were included. The median Body Mass Index (BMI) before revisional LAGB was 34.8 (interquartile range [IQR] 31.9–38.1) kg/m2. After a median follow-up of 33.5 (IQR 19.5–76.5) months, the median BMI was 28.7 (IQR 26.1–32.2) kg/m2. The median additional Excess Weight Loss (EWL) was 37.6% (IQR 23–44.4), leading to a median total EWL of 79.5% (IQR 54.4–94.6). BMI and EWL post-LAGB improved significantly compared to BMI and EWL pre-LAGB (p<0.001 and p<0.001, respectively). Obstructive sleep apnea syndrome resolved 6 months after LAGB in one patient. Three band deflations occurred during the follow-up. Six patients underwent band removal after a median time of 19 (IQR 15.8–26) months. Overall, thirteen patients underwent a reoperation. There was no loss of follow-up until 5 years. After that, two patients were lost to follow-up.
Conclusion
LAGB may be a salvage option after failed RYGB. However, the high rate of revisions after secondary LAGB needs to be taken into consideration.
Roux-en-Y gastric bypass (RYGB) is the gold standard in bariatric surgery. The effect of the procedure is based on restriction, malabsorption and changes in hormonal axis. Ghrelin is an important appetite hormone which is produced mainly in the gastric fundus. By adding a resection of the gastric fundus, we hypothesized that excessive weight loss will be more prominent and the satiety feelings less pronounced compared to standard RYGB. A total of 73 patients with standard very very long limb (VVLL) RYGB (group A) were compared with 44 patients with VVLL RYGB with resection of the fundus (group B). Outcome measures were excessive weight loss (EWL), body mass index (BMI), early postoperative morbidity, change of co-morbidities, and appetite reduction as assessed by an appetite questionnaire over a postoperative period of 24 months. Groups were comparable in basic preoperative descriptions. Additional fundus resection did not influence EWL (group A 66.1 % vs. group B 70.6 %, p = 0.383) or BMI (group A 29 kg/m(2) vs. group B 27 kg/m(2), p = 0.199). No significant difference in morbidity or change of co-morbidities occurred. The appetite and satiety questionnaire showed no difference between group A and group B, respectively. Adding a resection of the gastric fundus in RYGB did not alter the clinical results, i.e., increased excessive weight loss, decrease of appetite, or increase of satiety. The value of removing a part of the ghrelin-producing cells might be overestimated.
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