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Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.
The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.
The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard RYGB | Active Comparator | Standard RYGB |
|
| Extended Pouch RYGB | Experimental | Restrictive/extended pouch RYGB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Pouch RYGB | Procedure |
| ||
| Standard RYGB |
| Measure | Description | Time Frame |
|---|---|---|
| Weight reduction | Excess weight loss (%EWL) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in comorbidities | Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
This will be done for diabetes mellitus, hypertension, dyslipidemia and OSAS. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered. | 2 years |
| Quality of life |
Inclusion Criteria:
Patient eligible for bariatric surgery according Fried guidelines
Primary Gastric bypass
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Homan, MD | Rijnstate Hospital Arnhem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6800WC | Netherlands |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| Change in comorbidities | Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS. | 2 years |
The quality of life will be assessed by using the BAROS.
| 2 years |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |