Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic SASI.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome, Severe Obesity, Reflux, Gastroesophageal, Bariatric Surgery. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Endoscopic SASI
Endoscopic conversion to sleeve gastrectomy to SASI
Primary outcome measures
- Total amount of weight loss [Time frame: 6 months]
Secondary outcome measures (2)
- HbA1c [Time frame: 6 months]
- GERD symptoms [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
Subject must meet all the inclusion criteria to participate in this study and list each criterion.
- Age: 21-65 years
- Patients going for LSG at participating hospitals.
- 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
- Patients who were breast feeding or pregnant
- Severe psychiatric illness
- Eating disorder
- Active neoplastic disease
- End-stage renal disease
- Patients with bleeding diathesis
- Patients with pacemakers or implantable cardiac defibrillators
- Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
- 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)
- Treatment with anti-platelet agents that could not be temporarily discontinued
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Singapore · 3 centers
- Changi General Hospital — Singapore
- Sengkang General Hospital — Singapore
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT06757296 · 2024-3067