Morbid Obesity
Conditions
Brief summary
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
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)
Interventions
banded sleeve gastrectomy
DEVICEStandard SG
Standard SG
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Total Body Weight loss (%TBWL) | 3 years | ((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Excess Weight Loss (%EWL) | 3 years | ((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms |
| Quality of life due to questionnaire | 3 years | Measuring BAROS |
| Gastroesophageal reflux disease | 3 years | Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease. |
| Reduction of comorbidities | 3 years | Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA |
Countries
Netherlands
Outcome results
None listed