Extending and Banding the Roux-en-Y Gastric Bypass
- Conditions
- Morbid Obesity
- Interventions
- Procedure: Extended Pouch RYGBProcedure: Banded extended pouch RYGBProcedure: Standard RYGB
- Registration Number
- NCT05357807
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
- Detailed Description
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 375
- All patients who are eligible for a primary RYGB
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
- Renal impairment (MDRD <30)
- Hepatic dysfunction (liver function twice the normal values)
- Pregnancy during follow-up
- Patients with treatment-resistant reflux symptoms.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended Pouch RYGB Extended Pouch RYGB 127 patients undergo a Roux-en-Y gastric bypass with an extended pouch. Banded Extended RYGB Banded extended pouch RYGB 127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch. Standard RYGB Standard RYGB 127 patients undergo a standard Roux-en-Y gastric bypass
- Primary Outcome Measures
Name Time Method Percentage Total Body Weight Loss (%TBWL) 3 years ((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
- Secondary Outcome Measures
Name Time Method Percentage Excess Weight Loss (%EWL) 3 years ((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
BODY-Q: Quality of life after bariatric surgery 3 years BODY-Q: Patient reporterd outcome measurement, The questionnaire measures three domains; health related quality of life, appearance and experience of healthcare. Each domain is composed of independently functioning scales. Each scale contains different statements, which can be scored on four levels ranging from totally disagree to totally agree or from never to always. The sum of levels ranging from 1 to 4 is the raw score of the different scales. This score can be converted into a Rasch Transformed score ranging from 0, worst score, to 100, best score.
BAROS: Quality of life after bariatric surgery 3 years BAROS; evaluates the results of obesity treatments by analyzing 3 domains: weight loss, changes in co-morbidities, and quality of life. Up to 3 points are allowed for each, and points are deducted for complications and reoperations. The final score classifies the results in 5 outcome groups, providing an objective definition of success or failure.
SF-36: Quality of life after bariatric surgery 3 years SF-36; consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Gastroesophageal reflux disease 3 years GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Change in comorbidities in patients pre- and postoperative 3 years Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Trial Locations
- Locations (3)
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Utrecht, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands
NOK West
🇳🇱Den Haag, Netherlands