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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Weight Gain
• Intervention / Treatment: Procedure: Distal gastric bypass

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilian van Hogezand, MD; Phone Number: 0031548704498; Email: l.van.hogezand@antoniusziekenhuis.nl
• Study Contact Backup: Name: M.J. Wiezer, PhD, MD; Phone Number: 0031 6418 73500; Email: r.wiezer@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Recruiting
      • Medisch Centrum Leeuwarden
      • Contact: E.H. Jutte, PhD, MD; Phone Number: 0031 5828 66969; Email: ewoud.jutte@mcl.nl
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: E.J. Hazebroek, PhD, MD; Phone Number: 0031624242496; Email: ehazebroek@rijnstate.nl
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Not yet recruiting
      • Catharina Ziekenhuis
      • Contact: Simon Nienhuijs, MD, PhD; Phone Number: 0031402399850; Email: simon.nienhuijs@catharinaziekenhuis.nl
    • Roosendaal, Noord-Brabant, Netherlands, 4708 AE
      • Recruiting
      • Bravis hospital
      • Contact: B. Torensma, PhD, MD; Phone Number: 0031 1642 78800; Email: info@barttorensma.nl
    • Tilburg, Noord-Brabant, Netherlands, 5022 GC
      • Recruiting
      • Elisabeth-TweeSteden Hospital
      • Contact: B. Langenhoff, PhD, MD; Phone Number: 0031 1322 10310; Email: b.langenhoff@etz.nl
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1061 AE
      • Recruiting
      • OLVG
      • Contact: R.N. Van Veen, PhD, MD; Phone Number: 0031 2051 08040; Email: r.n.vanveen@olvg.nl
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Recruiting
      • St. Antonius Hospital
      • Contact: M.J. Wiezer, PhD, MD; Phone Number: 0031 6418 73500; Email: r.wiezer@antoniusziekenhuis.nl
      • Contact: Lilian van Hogezand, MD; Phone Number: 0031648704498; Email: l.van.hogezand@antoniusziekenhuis.nl
  • Zuid-Holland
    • Gouda, Zuid-Holland, Netherlands, 2803 HH
      • Not yet recruiting
      • Groene Hart Hospital
      • Contact: R.S.L. Liem, PhD, MD; Phone Number: 0031 7032 04703; Email: ronald.liem@ghz.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Distal gastric bypass; Distal gastric bypass, revisonal surgery after failed RYGB
Experimental: 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.	Procedure: Distal gastric bypass; Distal gastric bypass, revisonal surgery after failed RYGB

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Collaborators: Medtronic
• Investigators: Principal Investigator: M.J. Wiezer, PhD, MD, St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Weight regain; Failed RYGB; Distal gastric bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Obesity, Morbid; Weight Gain
• Other Study ID Numbers: NL75322.100.20/R20.093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No