Creating a Laparoscopic Banded Sleeve Gastrectomy
- Conditions
- Morbid Obesity
- Interventions
- Device: Banded Sleeve GastrectomyDevice: Standard SG
- Registration Number
- NCT04610099
- Lead Sponsor
- Rijnstate Hospital
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 211
- Alle patients who are eligible for a primary SG
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Banded SG Banded Sleeve Gastrectomy 100 patients undergo a banded sleeve gastrectomy Standard SG Standard SG 100 patients undergo a standard sleeve gastrectomy
- Primary Outcome Measures
Name Time Method Percentage Total Body Weight loss (%TBWL) 3 years ((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
- Secondary Outcome Measures
Name Time Method Reduction of comorbidities 3 years Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Gastroesophageal reflux disease 3 years Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
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 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
Trial Locations
- Locations (3)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands
Zuyderland Medisch Centrum
🇳🇱Heerlen, Limburg, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Utrecht, Netherlands