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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Morbid Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Distal gastric bypass type I

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.

Group Type EXPERIMENTAL

Distal gastric bypass

Intervention Type PROCEDURE

Distal gastric bypass, revisonal surgery after failed RYGB

Distal gastric bypass type II

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.

Group Type EXPERIMENTAL

Distal gastric bypass

Intervention Type PROCEDURE

Distal gastric bypass, revisonal surgery after failed RYGB

Interventions

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Distal gastric bypass

Distal gastric bypass, revisonal surgery after failed RYGB

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No