Creating a Laparoscopic Banded Sleeve Gastrectomy (RING)

Rijnstate Hospital

Status: Active, not recruiting

Conditions: Morbid Obesity

Treatments: Device: Banded Sleeve Gastrectomy; Device: Standard SG

Study type: Interventional

Funder types: Other

Identifiers

NCT04610099

NL70754.091.19

Details and patient eligibility

About

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.

Full 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)

Enrollment: 211 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 2 patient groups

Standard SG

Active Comparator group

Description:

100 patients undergo a standard sleeve gastrectomy

Treatment:

Device: Standard SG

Banded SG

Experimental group

Description:

100 patients undergo a banded sleeve gastrectomy

Treatment:

Device: Banded Sleeve Gastrectomy