Banded Versus Non-Banded Sleeve in Class IV Obese Patients

NCT ID: NCT07100327

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Banded Group

Placement of a 1.5 x 5.5 cm polypropylene band

Group Type: ACTIVE_COMPARATOR

Band

Intervention Type: PROCEDURE

Laparoscopic sleeve gastrectomy with the placement of a 1.5 x 5.5 cm polypropylene band around the proximal gastric pouch to enhance restriction.

Non-Banded Group

Standard laparoscopic sleeve gastrectomy

Group Type: PLACEBO_COMPARATOR

Non-Band

Intervention Type: PROCEDURE

Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure

Interventions

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.

Intervention Type: PROCEDURE

Non-Band

Standard laparoscopic sleeve gastrectomy where approximately 75-80% of the stomach is resected to form a tubular structure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-60 years
• BMI ≥ 50 kg/m² (Class IV obesity)
• No prior gastrointestinal surgeries
• No significant psychiatric or medical contraindications to surgery
• Ability to provide informed consent

Exclusion Criteria

• BMI < 50 kg/m²
• Refusal to undergo band placement
• Active reflux disease or PPI use
• Prior bariatric surgery
• Pregnancy plans during the study period
• Active cancer or life-limiting illness
• Substance abuse or non-compliance with postoperative care
• Gastroesophageal reflux disease.
• Hiatal hernia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Committee of Teaching Hospitals and Institutes, Egypt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed Hany Ashour

Professor of General surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Ashour, Ph.D. (Professor)

Role: PRINCIPAL_INVESTIGATOR

The surgical department of Medical Research Institute Hospital, Alexandria University

Locations

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

RCT Banded vs Non in Class IV

Identifier Type: -

Identifier Source: org_study_id