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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK138047-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.
The study will examine whether a modified vertical sleeve gastrectomy (mVSG) will improve GERD and quality of life.
Aim 1 (Primary): to determine whether mVSG, in comparison to conventional vertical sleeve gastrectomy (cVSG), will be associated with lower acid exposure time (AET, measured by the Bravo pH test) at 6-9 months. The investigators hypothesize that, at Month 6-9, compared to cVSG:
• H1. mVSG will be associated with lower AET
Aim 2 (Secondary): To elucidate the mechanistic basis for Aim 1, the investigators will perform following tests, before and at 6-9 months post-surgery: a) High resolution esophageal manometry (HREM) to determine the lower esophageal sphincter (LES) and intragastric pressure; b) The endoluminal functional lumen imaging probe (EndoFLIP) testing to examine changes in compliance of the LES; c) Measure the length of the gastroesophageal flap valve (GEFV) on the retroflex view during endoscopic exam. The investigators hypothesize that, at Month 6-9, compared to cVSG:
Aim 3: Examine the impact of GERD on quality of life (QoL) with two validated rating scales - Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) and Short Form-36 (SF-36). The investigators hypothesize that, at 12 months, compared to cVSG:
• H3. mVSG will lead to superior QoL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Vertical Sleeve Gastrectomy (mVSG) | Experimental | modified investigational vertical sleeve gastrectomy (mVSG) |
|
| Conventional Vertical Sleeve Gastrectomy (cVSG) | Active Comparator | conventional vertical sleeve gastrectomy (cVSG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Vertical Sleeve Gastrectomy (mVSG) | Procedure | The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Acid Exposure Time (%AET) | Change in %AET in percentage points at Month 6-9 relative to pre-surgery %AET assessed with the Bravo pH test | Pre-surgery, Month 6-9 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| LES pressure | Change in LES pressure in millimeters of mercury (mmHg) assessed with High Resolution Esophageal Manometry (HREM) | Pre-surgery, Month 6-9 post surgery |
| Intragastric pressure | Change in intragastric pressure in millimeters of mercury (mmHg) assessed with HREM |
| Measure | Description | Time Frame |
|---|---|---|
| GERD-HRQL score | Change in GERD-HRQL score assessed with GERD-HRQL questionnaire | Pre-surgery, Months 4, 6-9, 12 post surgery |
| Health-related quality of life | Change in SF-36 score assessed with SF-36 questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ninh T. Nguyen, MD | Contact | 714 456 8598 | ninhn@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ninh T. Nguyen, MD | University of California, Irvine | Principal Investigator |
| Ravinder K. Mittal, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Recruiting | Orange | California | 92628 | United States |
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| Conventional Vertical Sleeve Gastrectomy (cVSG) | Procedure | Vertical Sleeve Gastrectomy as standard procedure |
|
| Pre-surgery, Month 6-9 post surgery |
| LES compliance | Change in LES compliance in ratio of mm3/mmHg assessed with EndoFLIP | Pre-surgery, Month 6-9 post surgery |
| GEFV length | Change in GEFV length in millimeters (mm) assessed with endoscopic exam | Pre-surgery, Month 6-9 post surgery |
| Pre-surgery, Months 4, 6-9, 12 post surgery |
| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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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