Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT04894838

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid, Weight Gain

Full registry 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.