Creating a Laparoscopic Banded Sleeve Gastrectomy

Creating a Laparoscopic Banded 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.

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)

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