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A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.
A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.
Study is a prospective, randomized, multi centre trial.
Study population: patients who qualify for a SG are eligible to participate. The primary SG patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.
Intervention: The standard SG is compared with a banded-SG (BSG)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard SG | Active Comparator | 100 patients undergo a standard sleeve gastrectomy |
|
| Banded SG | Experimental | 100 patients undergo a banded sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banded Sleeve Gastrectomy | Device | banded sleeve gastrectomy |
|
| 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 |
| Quality of life due to questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazebroek | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6815AD | Netherlands | ||
| Zuyderland Medisch Centrum |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Standard SG | Device | Standard SG |
|
Measuring BAROS
| 3 years |
| Quality of life due to questionnaire | 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 |
| Quality of life due to questionnaire | 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 | Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease. | 3 years |
| Reduction of comorbidities | Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA | 3 years |
| Heerlen |
| Limburg |
| 6419PC |
| Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Utrecht | 3435CM | Netherlands |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |