Banded Roux-en-Y gastric bypass in patients with super morbid obesity (BRandY-study): protocol of a cohort study with 10 year follow-up

M M Romeijn,F M H Van Dielen,W K G Leclercq,L Janssen,A A P M Luijten

doi:10.1186/s12893-020-00784-x

M M Romeijn, F M H Van Dielen + Show 3 more

Open Access

https://doi.org/10.1186/s12893-020-00784-x

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Journal: BMC Surgery	Publication Date: Jun 5, 2020
Citations: 5	License type: open-access

Affiliation: Máxima Medisch Centrum, Radboud University Nijmegen

Abstract

BackgroundWeight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2). Non-response, either defined as insufficient weight loss or weight regain after initial successful weight loss, is a matter of serious concern in these patients. The primary banded Roux-en-Y gastric bypass has shown promising results regarding weight loss in the bariatric population. However, up to now, long-term comparative data about the banded and non-banded bypass in superobese patients is lacking. The aim of this study is to assess the added value of the banded Roux-en-Y gastric bypass in superobese patients on long-term weight loss outcomes.MethodsThis single center study will evaluate superobese patients who receive a non-banded Roux-en-Y gastric bypass (NB-RYGB) and a banded Roux-en-Y gastric bypass (B-RYGB). Data from the NB-RYGB group will be collected in retrospect, while data from the B-RYGB group will be collected prospectively. When performing a B-RYGB, a 7.0–8.0 cm silastic ring (MiniMizer®) will be placed proximal to the gastrojejunostomy. The main outcomes of this study are weight loss and non-response during a 10 year follow-up period. Secondary outcomes are reduction of obesity related comorbidities and medication, (ring-related) morbidity and mortality, complications, re-operations, patient satisfaction and health-related quality of life. A total of 142 patients will be included in this study.DiscussionThis study will help establish the clinical utility of the B-RYGB in superobese patients.Trial registerNL8093. Registered 15 October 2019 - Retrospectively registered on the Dutch Registry of Clinical trials, www.trialregister.nl

Highlights

Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2)
It is well established that bariatric surgery is an effective treatment for these patients, weight loss outcomes are less beneficial in patients with super morbid obesity
Where morbidly obese patients lose an average of 67% excess weight loss (EWL) in the first 2 years after Roux-en-Y gastric bypass (RYGB) [2], super obese patients lose between 48 and 59% [3, 4]

Summary

Introduction

Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2). Where morbidly obese patients lose an average of 67% excess weight loss (EWL) in the first 2 years after Roux-en-Y gastric bypass (RYGB) [2], super obese patients lose between 48 and 59% [3, 4]. Morbidly obese patients reach their maximal weight loss 1.9 years after surgery, while super obese patients reach this point after 2.2 years [5, 6] Another concern is that the rate of non-response after bariatric surgery seems to be more pronounced in superobese patients [7]. Long term studies have shown that superobese patients gain 5.2 BMI points 5 years after RYGB [7]. Ten years after RYGB 58% of superobese patients have strikingly returned to a BMI above 35 kg/m2 [5] not to mention the comorbidities that may have reoccurred

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