DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass

  • STATUS
    Recruiting
  • End date
    May 12, 2027
  • participants needed
    150
  • sponsor
    St. Antonius Hospital
Updated on 12 June 2021

Summary

This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers that have indicated that they are willing to participate pending ethical approval (St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden).

Description

Rationale: Up to 35% of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) fail to lose sufficient weight or regain excessive weight after initial weight loss. Currently, there is no standardized approach to revisional surgery after failed RYGB. Distalisation of the RYGB limbs (DGB), with shortening of the common channel and extending either the alimentary limb (AL) or biliopancreatic limb (BPL), can be performed as revisional surgery to induce additional weight loss. To date, there is no general consensus as to optimal surgical technique or limb lengths to be used in distalisation of RYGB in both literature as well as clinical practice.

Objective: The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM). In this randomised controlled trial DGB with lengthening of the BPL (DGB type I) will be compared to DGB with extended AL (DGB type II) in order to conclude which surgical technique is the optimal therapeutic strategy as revision surgery following Roux-en-Y gastric bypass.

Study design: A multicentre randomised controlled trial.

Study population: Morbidly obese patients with insufficient weight loss or weight regain following primary RYGB, who are eligible for distalisation surgery.

Intervention: A total of 150 participants will be randomised over two treatment groups: group A will undergo DGB type I and group B will undergo DGB type II.

Main study endpoints: Primary endpoints: %TWL 1 year after treatment and need for treatment of PCM. Secondary endpoints: weight loss, co-morbidity remission, PCM grading (debilitating defecation patterns, temporary total parenteral nutrition treatment, revision, mortality), morbidity, nutritional deficiencies, quality of life and patient satisfaction.

Details
Condition Morbid obesity, severe obesity, Weight Gain
Treatment Distal gastric bypass
Clinical Study IdentifierNCT04894838
SponsorSt. Antonius Hospital
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-65 years
BMI 40 kg/m2 or BMI 35 kg/m2 with obesity related comorbidity
Weight regain or insufficient weight loss (EWL<50% or TWL<20%)15,16 following RYGB
Multidisciplinary team screening at one of the bariatric centres
Informed consent and willing to enter the follow-up program

Exclusion Criteria

Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouch dilatation >50 mL, gastro-gastric fistula, gastro-jejunostomy)
Distalisation of RYGB is technical infeasible (judgment by surgeon)
Inflammatory bowel disease, celiac disease, irritable bowel syndrome and other causes of chronic diarrhea
Severe concomitant disease (such as carcinomas and neurodegenerative disorders)
Pregnant women
Noncompliance in follow-up or unwilling to undergo surgery
Inability of reading/understanding and filling out questionnaires
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