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

St. Antonius Hospital

Status: Enrolling

Conditions: Weight Gain; Obesity, Morbid

Treatments: Procedure: Distal gastric bypass

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04894838

NL75322.100.20/R20.093

Details and patient eligibility

About

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: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Distal gastric bypass type I

Experimental group

Description:

Laparoscopic distalisation of RYGB type I. The RYGB is modified by dividing the Roux limb (AL) at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long biliopancreatic limb (BPL). In cases of initial AL lengths shorter than 100 cm, the CC lengths should be adjusted to create a TALL of at least 300 cm.

Treatment:

Procedure: Distal gastric bypass

Distal gastric bypass type II

Experimental group

Description:

Laparoscopic distalisation of RYGB type II. The RYGB is modified by dividing the BPL at the jejuno-jejunal anastomosis and re-anastomosed distally to 200 cm from the ileocecal valve using linear staplers, creating a long AL.

Treatment:

Procedure: Distal gastric bypass