Magnetic bariatric revisional surgery for weight loss and GERD resolution
9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.
This study tests if a new type of weight loss surgery using magnets can help people with obesity and acid reflux feel better after previous weight loss surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Unidad Internacional de Cirugia Bariatrica y Metabolica Academic / other |
| Locations | 1 site (Maracaibo, Zulia) |
| Trial ID | NCT04945304 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the effectiveness of Roux-en-Y gastric bypass (RYGB) as a revisional surgery technique for patients with obesity and gastroesophageal reflux disease (GERD). The procedure is performed using a single port approach, allowing for minimally invasive surgery while addressing complications from previous bariatric surgeries. The study aims to evaluate the outcomes of this innovative surgical technique, which includes the use of magnets for better visualization and retraction during the operation. The lead surgeon has extensive experience in bariatric procedures, ensuring a high level of expertise in the execution of the surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are candidates for bariatric surgery and have a BMI greater than 30 kg/m2.
Not a fit: Patients with uncontrolled co-morbidities, those with pacemakers or other electromedical implants, and individuals with hepatic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve weight loss outcomes and resolve GERD symptoms in patients who have previously undergone bariatric surgery.
How similar studies have performed: While the use of magnetic techniques in surgery is gaining interest, this specific approach to revisional bariatric surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years * Candidate to bariatric surgery * Obesity * BMI Greater than 30 kg/m2 Exclusion Criteria: * Uncontrolled co-morbidities * patients with pacemakers, defibrillators, or other electromedical implants * Abnormal coagulation blood tests * Patients with hepatic diseases
Where this trial is running
Maracaibo, Zulia
- Unidad Internacional de Cirugía Bariátrica y Metabólica — Maracaibo, Zulia, Venezuela (Recruiting)
Study contacts
- Principal investigator: Guillermo Borjas, MD. PhD — International Unit of Bariatric and Metabolic Surgery
- Study coordinator: Guillermo Borjas, MD. PhD
- Email: drguillermoborjas@hotmail.com
- Phone: 4146863041
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.