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

NCT04894838 | Recruiting DMC

• 1 other identifier: NL75322.100.20/R20.093
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Obesity, Morbid; Weight Gain

Keywords

Obesity; Weight regain; Failed RYGB; Distal gastric bypass

Outcome Measures

Primary Outcomes (2)

• Weight loss

  Percentage total weight loss (%TWL) 1 year after treatment

  1 year post-operative

• Number of Participants with development of protein calorie malnutrition (PCM)

  \>6 times/day defecation patterns with diarrhea, assessed by fecal score questionnaire

  1 year postoperative

Secondary Outcomes (9)

• Weight loss

  Up to 3 year follow up

• TWL

  3, 6, 12, 18, 24, 36 month follow up

• Defecation pattern

  3, 12 and 36 months postoperative

• PCM grading

  up to 3 year follow up

• Complications

  uo to 3 year follow up

Study Arms (2)

Distal gastric bypass type I

EXPERIMENTAL

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.

Procedure: Distal gastric bypass

Distal gastric bypass type II

EXPERIMENTAL

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.

Procedure: Distal gastric bypass

Interventions

Distal gastric bypass PROCEDURE

Distal gastric bypass, revisonal surgery after failed RYGB

Distal gastric bypass type I; Distal gastric bypass type II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Medtronic: collaborator

Study Sites (8)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

NOT YET RECRUITING

Bravis Hospital

Roosendaal, North Brabant, 4708 AE, Netherlands

RECRUITING

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

OLVG

Amsterdam, North Holland, 1061 AE, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Groene Hart Hospital

Gouda, South Holland, 2803 HH, Netherlands

NOT YET RECRUITING

St. Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Weight Gain; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• M.J. Wiezer, PhD, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luna Tolenaars, MD

CONTACT

0031636434456; l.tolenaars@antoniusziekenhuis.nl

M.J. Wiezer, PhD, MD

CONTACT

0031 6418 73500; r.wiezer@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who meet the eligibility criteria will be included in this trial at the outpatient clinic of the participating bariatric centres after informed consent is obtained. The participating patients will be randomised into one of the surgical techniques: type I or type II DGB. Randomisation will take place in the operating room through an internet-based randomisation system in REDCap. Only the participants are blinded to the treatment allocation. The randomisation table will be created by an independent epidemiologist in the St. Antonius hospital, ensuring concealment of treatment allocation. Participants will be randomised in equal numbers to both interventions. The randomisation will be stratified by participating hospitals to ensure participants are evenly allocated to each treatment arm at each participation hospital.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. M.J. Wiezer

Model Details: In total, 150 morbidly obese patients are eligible for distalisation surgery following RYGB. The participants will be randomised into DGB type I (group a) or DGB type II (group b). The study population consists of morbidly obese patients with insufficient weight loss or weight regain following primary Roux-en-Y gastric bypass, who are eligible for distalisation surgery.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 20, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8)