NCT07100327Completed
Banded Versus Non-Banded Sleeve in Class IV Obese Patients
Randomized Controlled Trial (RCT) of Banded Versus Non-Banded Sleeve Gastrectomy in Class IV Obese Patients: 3-Year Follow-up
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 219 (actual)
- First submitted
- 17 Jul 2025
- Start date
- 15 Jun 2022
- Primary completion date
- 15 Jun 2025
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Diseases
- Obesity
- NCT number
- NCT07100327
What you commit to
- Study type: Interventional
- Participants enrolled: 219
- From 15 Jun 2022 to the primary completion date, 15 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bariatric surgery
Other illness
- Active reflux disease or PPI use
- Active cancer or life-limiting illness
- Gastroesophageal reflux disease.
Other
- BMI \< 50 kg/m²
- Refusal to undergo band placement
- Pregnancy plans during the study period
- Substance abuse or non-compliance with postoperative care
- Hiatal hernia.
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.