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Banded Versus Non-Banded Sleeve in Class IV Obese Patients

NCT07100327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Morbid Obesity Requiring Bariatric Surgery

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

Sponsors & Collaborators

  • General Committee of Teaching Hospitals and Institutes, Egypt

    lead OTHER_GOV

Principal Investigators

  • Mohamed Ashour, Ph.D. (Professor) · The surgical department of Medical Research Institute Hospital, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2025-06-15
Completion
2025-07-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100327 on ClinicalTrials.gov