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| Name | Class |
|---|---|
| New You Medical Center | UNKNOWN |
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In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.
This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory Care Laparoscopic sleeve gastrectomy | Experimental | Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge |
|
| Next Day Discharge Laparoscopic sleeve gastrectomy | Active Comparator | Laparoscopic sleeve gastrectomy with next day discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory Laparoscopic Sleeve Gastrectomy | Procedure | Same-day discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Readmission | Readmission to hospital after discharge | up to 12 months after surgery |
| Number of patients undergoing reoperative or revisional surgical or endoscopic intervention | Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications | up to 12 months |
| Hospital Transfer | Transfer of patient in Ambulatory LSG group to hospital for postop stay | up to 16 hours |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...) | within 30 days |
| Mortality | Postoperative 30-day mortality rate | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing. | 3 months, 6 months, and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aayed Alqahtani, MD FRCSC | New You Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New You Medical Center | Riyadh | Saudi Arabia |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Conventional Laparoscopic Sleeve Gastrectomy | Procedure | Next-day discharge |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |