DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Distal gastric bypass.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid, Weight Gain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Procedure Distal gastric bypass
Distal gastric bypass, revisonal surgery after failed RYGB
Primary outcome measures
- Weight loss [Time frame: 1 year post-operative]
- Number of Participants with development of protein calorie malnutrition (PCM) [Time frame: 1 year postoperative]
Secondary outcome measures (9)
- Weight loss [Time frame: Up to 3 year follow up]
- TWL [Time frame: 3, 6, 12, 18, 24, 36 month follow up]
- Defecation pattern [Time frame: 3, 12 and 36 months postoperative]
- PCM grading [Time frame: up to 3 year follow up]
- Complications [Time frame: uo to 3 year follow up]
- Quality of life questionnaire [Time frame: 3, 12 and 36 months postoperative]
- Impact defecation pattern questionnaire [Time frame: 3, 12 and 36 months postoperative]
- Patient satisfaction questionnaire [Time frame: 1 and 3 year postoperative]
- Eating behaviour questionnaire [Time frame: 3, 12 and 36 months postoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 8 centers
- Rijnstate Hospital — Arnhem
- Catharina Ziekenhuis — Eindhoven
- Bravis Hospital — Roosendaal
- Elisabeth-Tweesteden Hospital — Tilburg
- OLVG — Amsterdam
- Medisch Centrum Leeuwarden — Leeuwarden
- Groene Hart Hospital — Gouda
- St. Antonius hospital — Nieuwegein
Identifiers
NCT: NCT04894838 · NL75322.100.20/R20.093