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

Study Overview
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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.

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.

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

Conditions
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Obesity, Morbid, Weight Gain

Intervention / Treatment
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* Procedure: Distal gastric bypass


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal gastric bypass type I<br>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<br>* Distal gastric bypass, revisonal surgery after failed RYGB<br>|
| Experimental: Distal gastric bypass type II<br>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<br>* Distal gastric bypass, revisonal surgery after failed RYGB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Patient weight in kilograms is collected preoperative up to 3 years follow-up to determine weight loss. | Up to 3 year follow up | 
| TWL | Weight loss in kilograms at a follow-up time point divided by weight in kilograms measured at DGB | 3, 6, 12, 18, 24, 36 month follow up | 
| Defecation pattern | Faecal score questionnaire to measure defecation frequencey and consistency | 3, 12 and 36 months postoperative | 
| PCM grading | Information is collected about each patient who has undergone DGB to ascertain debilitating defecation patterns (grade I), requirement of f participants requiring temporary total parenteral nutrition (grade II, revision surgery (grade III), and mortality (grade IV) after DGB. | up to 3 year follow up | 
| Complications | Information is collecting regarding the occurrence of one or more defined adverse events following DGB. Defined adverse events collected are: unplanned readmission to hospital, unplanned admission to the intensive care unit, unplanned return to the operating theatre, prolonged length of stay in hospital, and death. The reason for any of the events is also collected. If death occurs, the cause of death is collected to determine the likelihood of the death being caused by the DGB. | uo to 3 year follow up | 
| Quality of life questionnaire | BODY-Q questionnaire | 3, 12 and 36 months postoperative | 
| Impact defecation pattern questionnaire | Fecal incontinence quality of life scale FIQL questionnaires | 3, 12 and 36 months postoperative | 
| Patient satisfaction questionnaire | Self-designed 5-point scale measuring instrument for patient satisfaction | 1 and 3 year postoperative | 
| Eating behaviour questionnaire | Three factor earing questionnaire TFEQ R21 | 3, 12 and 36 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight regain, Failed RYGB, Distal gastric bypass