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COMPLETED
NCT07100327
NA

Banded Versus Non-Banded Sleeve in Class IV Obese Patients

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

219

Start Date

2022-06-15

Completion Date

2025-07-15

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

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

Locations (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt