Laparoscopic gastric banding using natural tissue for obesity treatment
Laparoscopic Natural Gastric Banding for Management of Morbid Obesity
This study is testing a new way to help people with severe obesity lose weight by using natural tissue instead of synthetic bands during laparoscopic gastric banding surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 2 sites (Minya and 1 other locations) |
| Trial ID | NCT05912920 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel approach to gastric banding for morbid obesity by utilizing the round ligament or omental flap instead of synthetic bands, which have been associated with numerous complications. The study aims to assess the safety and effectiveness of this technique in patients who are eligible for laparoscopic surgery. Participants will include obese individuals with a BMI over 40 or over 35 with co-morbidities, who have previously undergone restrictive bariatric procedures. The trial will evaluate outcomes related to weight loss and overall health improvements following the intervention.
Who should consider this trial
Good fit: Ideal candidates are obese patients aged 18 to 60 with a BMI over 40 or over 35 with co-morbidities who are fit for laparoscopic surgery.
Not a fit: Patients who are unfit for surgery, aged under 18 or over 60, or have had previous upper abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce complications associated with synthetic bands and improve weight loss outcomes for patients with morbid obesity.
How similar studies have performed: While the use of synthetic bands has been widely studied, this novel approach using natural tissue is relatively untested, making it a potentially innovative method in obesity treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity * patients fit for laparoscopic surgery * give approval to share in the study * previous restrictive bariatric procedure Exclusion Criteria: * patients unfit for surgery * patients aged less than 18 and older than 60 * patient with previous upper abdominal surgery either for obesity or other diseases
Where this trial is running
Minya and 1 other locations
- Faculty of medicine — Minya, Egypt (Recruiting)
- Minia university hospital — Minya, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.