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NCT Number: NCT07100327

Banded Versus Non-Banded Sleeve in Class IV Obese Patients

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.

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Key information

Conditions

Morbid Obesity Requiring Bariatric Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Non-Band

Procedure

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

Primary outcomes

  1. Total Weight Loss (TWL)

    Time frame: Measured at 6, 12, 24 and 36 months postoperatively

    Total Weight Loss between the 2 groups (in kilograms)

Secondary outcomes

  1. Resolution of associated medical problems

    Time frame: 6, 12, 24, and 36 months.

    Improvement or resolution of conditions like type 2 diabetes. Your doctor or a healthcare professional will perform a simple blood test, which may involve a finger prick or drawing blood from your arm.

    If a finger prick is used, you may get immediate results. If blood is sent to a lab, results are typically available within a day.

    The HbA1c (Hemoglobin A1c) test is a blood test used to measure your average blood sugar (glucose) levels over the past two to three months, providing a long-term indicator of blood glucose control and helping to diagnose and monitor diabetes and prediabetes.

    An HbA1c level below 5.7% is considered healthy. A result between 5.7% and 6.4% indicates prediabetes. A result of 6.5% or higher on two separate tests is used to diagnose diabetes. For individuals with diabetes, the HbA1c test helps monitor the effectiveness of diabetes management.

  2. Resolution of associated medical problems

    Time frame: 6, 12, 24, and 36 months.

    Improvement or resolution of conditions like hypertension. Blood pressure is measured in millimeters of mercury (mmHg) and is expressed as two numbers: systolic pressure (when the heart beats) over diastolic pressure (when the heart rests). A normal blood pressure reading is generally considered to be below 120/80 mmHg.

    Normal Blood Pressure: Generally, a reading of 120/80 mmHg or lower is considered normal.

    High Blood Pressure (Hypertension): Readings of 130/80 mmHg or higher are generally considered high.

  3. Resolution of associated medical problems

    Time frame: 6, 12, 24, and 36 months.

    Improvement or resolution of conditions like obstructive sleep apnea. Obstructive Sleep Apnea (OSA) severity is primarily measured using the Apnea-Hypopnea Index (AHI), which quantifies the number of breathing interruptions (apneas) and reduced airflow episodes (hypopneas) per hour of sleep. The AHI, determined through polysomnography (PSG), categorizes OSA as mild (AHI 5-14), moderate (AHI 15-30), or severe (AHI >30).

  4. Resolution of associated medical problems

    Time frame: 6, 12, 24, and 36 months.

    Improvement or resolution of conditions like hyperlipidemia. Hyperlipidemia, or high cholesterol, is measured through a lipid panel, a blood test that assesses various types of cholesterol and triglycerides, with results typically reported in milligrams per deciliter (mg/dL). This test usually requires a period of fasting beforehand, and a healthcare professional will draw a blood sample from a vein.

  5. Complications

    Time frame: post operative, 12, 24, and 36 months

    Postoperative complications classified by the Clavien-Dindo system.

  6. Food Intolerance

    Time frame: 12, 24, and 36 months

    Measured through patient-reported outcomes using the validated food intolerance questionnaire by Suter et al.

  7. Volumetric Analysis

    Time frame: 12, 24, and 36 months

    Evaluation of the gastric pouch volume postoperatively using radiographic imaging or endoscopic techniques

  8. Quality of Life (QOL)

    Time frame: 6, 12, 24, and 36 months

    Assessed using validated questionnaires such as the SF-36

  9. BODY-Q

    Time frame: 12, 24, and 36 months

    Assessed using validated questionnaires

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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