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

Obesity, Morbid Clinical Trial

— DISCOURSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894838
• Other study ID #: NL75322.100.20/R20.093
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 2027

Study information

• Verified date: November 2022
• Source: St. Antonius Hospital
• Contact: Lilian van Hogezand, MD
• Phone: 0031548704498
• Email: l.van.hogezand[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Gain

Intervention

Procedure:
• Distal gastric bypass
Distal gastric bypass, revisonal surgery after failed RYGB

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam	Noord-Holland
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Netherlands	Groene Hart Hospital	Gouda	Zuid-Holland
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	St. Antonius hospital	Nieuwegein	Utrecht
Netherlands	Bravis Hospital	Roosendaal	Noord-Brabant
Netherlands	Elisabeth-Tweesteden Hospital	Tilburg	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Medtronic

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Percentage total weight loss (%TWL) 1 year after treatment	1 year post-operative
Primary	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	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
Secondary	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
Secondary	Defecation pattern	Faecal score questionnaire to measure defecation frequencey and consistency	3, 12 and 36 months postoperative
Secondary	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
Secondary	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
Secondary	Quality of life questionnaire	BODY-Q questionnaire	3, 12 and 36 months postoperative
Secondary	Impact defecation pattern questionnaire	Fecal incontinence quality of life scale FIQL questionnaires	3, 12 and 36 months postoperative
Secondary	Patient satisfaction questionnaire	Self-designed 5-point scale measuring instrument for patient satisfaction	1 and 3 year postoperative
Secondary	Eating behaviour questionnaire	Three factor earing questionnaire TFEQ R21	3, 12 and 36 months postoperative