DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity Morbid
- Weight Gain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: Single (Participant)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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),...
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.
Tracking Information
- NCT #
- NCT04894838
- Collaborators
- Medtronic
- Investigators
- Principal Investigator: M.J. Wiezer, PhD, MD St. Antonius Hospital
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