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

Last updated: April 24, 2026
Sponsor: St. Antonius Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Treatment

Distal gastric bypass

Clinical Study ID

NCT04894838
NL75322.100.20/R20.093
  • Ages 18-65
  • All Genders

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Failed Roux-en-Y gastric bypass due to anatomic, surgical reasons (gastric pouchdilatation >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 othercauses 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.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Distal gastric bypass
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Rijnstate Hospital

    Arnhem, Gelderland 6815 AD
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven, North Brabant 5623 EJ
    Netherlands

    Site Not Available

  • Bravis Hospital

    Roosendaal, North Brabant 4708 AE
    Netherlands

    Active - Recruiting

  • Elisabeth-Tweesteden Hospital

    Tilburg, North Brabant 5022 GC
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam, North Holland 1061 AE
    Netherlands

    Active - Recruiting

  • Medisch Centrum Leeuwarden

    Leeuwarden, Provincie Friesland 8934 AD
    Netherlands

    Active - Recruiting

  • Groene Hart Hospital

    Gouda, South Holland 2803 HH
    Netherlands

    Site Not Available

  • St. Antonius hospital

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Active - Recruiting

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