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

ConditionsObesity, MorbidWeight Gain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Antonius Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Distal gastric bypass

    Procedure/Surgery

    Distal gastric bypass, revisonal surgery after failed RYGB

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Distal gastric bypass type IExperimental treatment 1 intervention
Group B: Distal gastric bypass type IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight loss

Percentage total weight loss (%TWL) 1 year after treatment

Time frame
1 year post-operative
2

Number of Participants with development of protein calorie malnutrition (PCM)

\>6 times/day defecation patterns with diarrhea, assessed by fecal score questionnaire

Time frame
1 year postoperative

Secondary outcomes

1

Weight loss

Patient weight in kilograms is collected preoperative up to 3 years follow-up to determine weight loss.

Time frame
Up to 3 year follow up
2

TWL

Weight loss in kilograms at a follow-up time point divided by weight in kilograms measured at DGB

Time frame
3, 6, 12, 18, 24, 36 month follow up
3

Defecation pattern

Faecal score questionnaire to measure defecation frequencey and consistency

Time frame
3, 12 and 36 months postoperative
4

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.

Time frame
up to 3 year follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Antonius Hospital

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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