Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
Metabolic SyndromeSevere ObesityReflux, GastroesophagealBariatric Surgery
Investigational drug(s) / intervention(s)
Endoscopic SASI
Endoscopic SASI: Endoscopic conversion to sleeve gastrectomy to SASI
Study summary
The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.
Eligibility
Sex
ALL
Min age
21 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Total amount of weight loss — 6 months Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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