Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

Launched by SINGAPORE HEALTH SERVICES · Dec 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new procedure that may help people who have had surgery for weight loss (called sleeve gastrectomy) but are still experiencing severe acid reflux or haven't lost enough weight. The goal is to see if using a special device to connect the stomach to a part of the intestine (ileum) can help improve symptoms and weight loss after a failed sleeve gastrectomy.

To participate, individuals must be between the ages of 21 and 65 and be scheduled for sleeve gastrectomy at one of the participating hospitals. They should also be able to understand and agree to the study. However, those who are pregnant, have certain serious health conditions, or have issues that might make it hard for them to follow the study rules won’t be able to join. If you decide to take part, you can expect to be monitored closely to see how well this new approach works for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject must meet all the inclusion criteria to participate in this study and list each criterion.
• • 1. Age: 21-65 years
• • 2. Patients going for LSG at participating hospitals.
• • 3. Able to provide informed consent
• • Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.
• Exclusion Criteria:
• • 1. Patients who were breast feeding or pregnant
• • 2. Severe psychiatric illness
• • 3. Eating disorder
• • 4. Active neoplastic disease
• • 5. End-stage renal disease
• • 6. Patients with bleeding diathesis
• • 7. Patients with pacemakers or implantable cardiac defibrillators
• • 8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
• • 9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
• • 10. Treatment with anti-platelet agents that could not be temporarily discontinued