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| Name | Class |
|---|---|
| Changi General Hospital | OTHER |
| Sengkang General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Endoscopic SASI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic SASI | Procedure | Endoscopic conversion to sleeve gastrectomy to SASI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of weight loss | Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c levels will be measured and reported in percentage (%) | 6 months |
| GERD symptoms | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility & Safety | 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. | 30 days |
Inclusion Criteria:
Subject must meet all the inclusion criteria to participate in this study and list each criterion.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chin Hong Lim, MD | Contact | 62223322 | lim.chin.hong@singhealth.com.sg | |
| Wei Min Chong, MSc | Contact | chong.wei.min@sgh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Chin Hong Lim, MD | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
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| 6 months |
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
|
| Singapore General Hospital | Recruiting | Singapore | Singapore |
|
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009767 | Obesity, Morbid |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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