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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
OLVG
RECRUITING
Amsterdam
Rijnstate Hospital
RECRUITING
Arnhem
Catharina Ziekenhuis
NOT_YET_RECRUITING
Eindhoven
Groene Hart Hospital
NOT_YET_RECRUITING
Gouda
Medisch Centrum Leeuwarden
RECRUITING
Leeuwarden
St. Antonius hospital
RECRUITING
Nieuwegein
Bravis Hospital
RECRUITING
Roosendaal
Elisabeth-Tweesteden Hospital
RECRUITING
Tilburg
Contact Information
Primary
Luna Tolenaars, MD
l.tolenaars@antoniusziekenhuis.nl
0031636434456
Backup
M.J. Wiezer, PhD, MD
r.wiezer@antoniusziekenhuis.nl
0031 6418 73500
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2027-05
Participants
Target number of participants: 150
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov