Bariatric Surgery, Metabolic Syndrome, Reflux, Gastroesophageal, Severe Obesity
Conditions
Keywords
SASI, Severe Obesity, Bariatric Surgery
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.
Interventions
PROCEDUREEndoscopic SASI
Endoscopic conversion to sleeve gastrectomy to SASI
Sponsors
Changi General Hospital
Sengkang General Hospital
Singapore Health Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility & Safety | 30 days | Technical success rate & procedure related complications. Number of adverse events will be recorded at all times to determine the feasibility and safety of the study procedure. |
Countries
Singapore
Contacts
Primary ContactChin Hong Lim, MD
Backup ContactWei Min Chong, MSc
Outcome results
None listed