Banded Versus Non-Banded Sleeve in Class IV Obese Patients

General Committee of Teaching Hospitals and Institutes, Egypt

Status: Completed

Conditions: Morbid Obesity Requiring Bariatric Surgery

Treatments: Procedure: Band; Procedure: Non-Band

Study type: Interventional

Funder types: Other

Identifiers

NCT07100327

RCT Banded vs Non in Class IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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219 participants in 2 patient groups, including a placebo group

Banded Group

Active Comparator group

Description:

Placement of a 1.5 x 5.5 cm polypropylene band

Treatment:

Procedure: Band

Non-Banded Group

Placebo Comparator group

Description:

Standard laparoscopic sleeve gastrectomy

Treatment:

Procedure: Non-Band