Creating a Laparoscopic Banded Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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)

Official Title
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Creating a Laparoscopic Banded Sleeve Gastrectomy

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Banded Sleeve Gastrectomy
* Device: Standard SG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alle patients who are eligible for a primary SG Exclusion Criteria: Bariatric surgery in medical history BMI > 60kg/m2 or a planned two-stage procedure. 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) or hepatic dysfunction (liver function twice the normal values) Pregnancy during follow-up Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

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 SG<br>100 patients undergo a standard sleeve gastrectomy | Device: Standard SG<br>* Standard SG<br>|
| Experimental: Banded SG<br>100 patients undergo a banded sleeve gastrectomy | Device: Banded Sleeve Gastrectomy<br>* banded sleeve gastrectomy<br>* Other names: BSG;|

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 | 
| Quality of life due to questionnaire | 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 |