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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard RYGB | Active Comparator | 127 patients undergo a standard Roux-en-Y gastric bypass |
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| Extended Pouch RYGB | Experimental | 127 patients undergo a Roux-en-Y gastric bypass with an extended pouch. |
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| Banded Extended RYGB | Experimental | 127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard RYGB | Procedure | Roux-en-Y Gastric bypass |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6815AD | Netherlands | ||
| St. Antonius Ziekenhuis |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Extended Pouch RYGB | Procedure | Roux-en-Y gastric bypass with an extended pouch |
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| Banded extended pouch RYGB | Procedure | Roux-en-Y gastric bypass with a banded extended pouch |
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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 |
| Nieuwegein |
| Utrecht |
| 3435CM |
| Netherlands |
| NOK West | The Hague | Netherlands |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |