Clinical trial NCT04894838: DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Official title: DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Weight Gain
Keywords: Obesity
Weight regain
Failed RYGB
Distal gastric bypass
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2021-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight loss
timeFrame: 1 year post-operative
measure: Number of Participants with development of protein calorie malnutrition (PCM)
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Weight loss
timeFrame: Up to 3 year follow up
measure: TWL
timeFrame: 3, 6, 12, 18, 24, 36 month follow up
measure: Defecation pattern
timeFrame: 3, 12 and 36 months postoperative
measure: PCM grading
timeFrame: up to 3 year follow up
measure: Complications
timeFrame: uo to 3 year follow up
measure: Quality of life questionnaire
timeFrame: 3, 12 and 36 months postoperative
measure: Impact defecation pattern questionnaire
timeFrame: 3, 12 and 36 months postoperative
measure: Patient satisfaction questionnaire
timeFrame: 1 and 3 year postoperative
measure: Eating behaviour questionnaire
timeFrame: 3, 12 and 36 months postoperative
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Bravis Hospital
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elisabeth-Tweesteden Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius hospital
state: Utrecht
city: Gouda
country: Netherlands
facility: Groene Hart Hospital
state: Zuid-Holland
Study officials:
affiliation: St. Antonius Hospital
name: M.J. Wiezer, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: