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New treatment option for Obesity, Morbid
Official title DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass
ClinicalTrials.gov ID: NCT04894838
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Arnhem, Gelderland, Netherlands
- Eindhoven, North Brabant, Netherlands
- Roosendaal, North Brabant, Netherlands
- Tilburg, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Leeuwarden, Provincie Friesland, Netherlands
- Gouda, South Holland, Netherlands
- Nieuwegein, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arnhem, Gelderland, Netherlands; Eindhoven, North Brabant, Netherlands; Roosendaal, North Brabant, Netherlands; Tilburg, North Brabant, Netherlands; Amsterdam, North Holland, Netherlands; Leeuwarden, Provincie Friesland, Netherlands and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.