NCT07100327

Banded Versus Non-Banded Sleeve in Class IV Obese Patients

Randomized Controlled Trial (RCT) of Banded Versus Non-Banded Sleeve Gastrectomy in Class IV Obese Patients: 3-Year Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Obesity remains a major global health challenge, with Class IV super obesity (BMI ≥ 50 kg/m²) being the most severe form. This condition is associated with numerous comorbidities including type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia, which significantly reduce life expectancy and quality of life. Bariatric surgery, particularly sleeve gastrectomy (SG), has been shown to be an effective treatment for morbid obesity. While SG results in significant weight loss and improvement of comorbidities, some patients experience weight regain over time. Banded sleeve gastrectomy (BSG) has been proposed as a modification of SG to enhance long-term outcomes by providing additional restriction via a polypropylene band around the proximal gastric pouch. Although initial evidence for banded procedures suggests improved outcomes, particularly in the context of weight loss and reduced weight regain, specific evidence for Class IV obesity remains limited.

Detailed description

This study aims to evaluate the effectiveness of adding a band to sleeve gastrectomy in patients with Class IV obesity by comparing weight loss, comorbidity resolution, complications, and quality of life outcomes over a 3-year period.

Conditions

• Morbid Obesity Requiring Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Band	Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction.
PROCEDURE	Non-Band	Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-06-15
• Completion: 2025-07-15
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: Egypt