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

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Severe Obesity; Reflux, Gastroesophageal; Bariatric Surgery

• Registration Number: NCT06757296
• Lead Sponsor: Singapore Health Services

Brief 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.

Detailed Description

The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy.

However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently.

In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.

Study Timeline

• Study First Submitted: 2024-01-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Study Start: 2025-02-03
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-08-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 (%).

Secondary Outcome Measures

Name	Time	Method
HbA1c	6 months	HbA1c levels will be measured and reported in percentage (%)
GERD symptoms	6 months	Quality of Life in Reflux And Dyspepsia (QoLRAD) is a questionnaire used to assess how gastroesophageal reflux disease (GERD) and dyspepsia (indigestion) affects a person's quality of life.; The total score will be calculated from the questionnaire and a reduction in QoLRAD score over time will demonstrate improvement.

Trial Locations

Locations (3)

Changi General Hospital; 🇸🇬 Singapore, Singapore

Sengkang General Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore