Extending and Banding the Roux-en-Y Gastric Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extending and Banding the Roux-en-Y Gastric Bypass

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Standard RYGB
* Procedure: Extended Pouch RYGB
* Procedure: Banded extended pouch RYGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are eligible for a primary RYGB Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard RYGB<br>127 patients undergo a standard Roux-en-Y gastric bypass | Procedure: Standard RYGB<br>* Roux-en-Y Gastric bypass<br>* Other names: S-RYGB;|
| Experimental: Extended Pouch RYGB<br>127 patients undergo a Roux-en-Y gastric bypass with an extended pouch. | Procedure: Extended Pouch RYGB<br>* Roux-en-Y gastric bypass with an extended pouch<br>* Other names: EP-RYGB;|
| Experimental: Banded Extended RYGB<br>127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch. | Procedure: Banded extended pouch RYGB<br>* Roux-en-Y gastric bypass with a banded extended pouch<br>* Other names: BEP-RYGB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Total Body Weight Loss (%TBWL) | ((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Excess Weight Loss (%EWL) | ((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms | 3 years | 
| BODY-Q: Quality of life after bariatric surgery | 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. | 3 years | 
| BAROS: Quality of life after bariatric surgery | 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. | 3 years | 
| SF-36: Quality of life after bariatric surgery | 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 | 3 years | 
| Gastroesophageal reflux disease | GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease. | 3 years | 
| Change in comorbidities in patients pre- and postoperative | Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA | 3 years |