Banded Versus Non-Banded Sleeve in Class IV Obese Patients

NCT07100327 | Completed

• 1 other identifier: RCT Banded vs Non in Class IV
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity Requiring Bariatric Surgery

Keywords

Class IV Obese Patients; Banded versus Non-Banded Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Total Weight Loss (TWL)

  Total Weight Loss between the 2 groups (in kilograms)

  Measured at 6, 12, 24 and 36 months postoperatively

Secondary Outcomes (9)

• Resolution of associated medical problems

  6, 12, 24, and 36 months.

• Resolution of associated medical problems

  6, 12, 24, and 36 months.

• Resolution of associated medical problems

  6, 12, 24, and 36 months.

• Resolution of associated medical problems

  6, 12, 24, and 36 months.

• Complications

  post operative, 12, 24, and 36 months

Study Arms (2)

Banded Group

ACTIVE COMPARATOR

Placement of a 1.5 x 5.5 cm polypropylene band

Procedure: Band

Non-Banded Group

PLACEBO COMPARATOR

Standard laparoscopic sleeve gastrectomy

Procedure: Non-Band

Interventions

Band 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.

Banded Group

Non-Band PROCEDURE

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

Non-Banded Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

Location

MeSH Terms

Interventions

Chromosome Banding; Chloride-Bicarbonate Antiporters

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Investigative Techniques; Genetic Techniques; Antiporters; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; SLC4A Proteins; Solute Carrier Proteins; Membrane Glycoproteins; Membrane Proteins

Study Officials

• Mohamed Ashour, Ph.D. (Professor)

  The surgical department of Medical Research Institute Hospital, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Model Details: * Banded Group: 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 where approximately 75-80% of the stomach is resected to form a tubular structure.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 3, 2025
• Study Start: June 15, 2022
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: whole study period
• Access Criteria: Ask contact person

Locations

EG (1)