Obesity, Morbid
Conditions
Keywords
sleeve gastrectomy, ambulatory surgery, day case surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAmbulatory Laparoscopic Sleeve Gastrectomy
Same-day discharge
PROCEDUREConventional Laparoscopic Sleeve Gastrectomy
Next-day discharge
Sponsors
New You Medical Center
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 65 years 2. Body mass index \<60 3. American Anesthesiologists Association classification ≤III 4. Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery
Exclusion criteria
1. High risk for thromboembolic disease 2. Has a history of major open abdominal surgery 3. Bleeding disorders 4. Heart disease 5. Pulmonary hypertension 6. Uncontrolled type 2 diabetes 7. Severe obstructive sleep apnea 8. Chronic obstructive pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readmission | up to 12 months after surgery | Readmission to hospital after discharge |
| Number of patients undergoing reoperative or revisional surgical or endoscopic intervention | up to 12 months | Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications |
| Hospital Transfer | up to 16 hours | Transfer of patient in Ambulatory LSG group to hospital for postop stay |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | within 30 days | Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...) |
| Mortality | up to 30 days | Postoperative 30-day mortality rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 3 months, 6 months, and 1 year | Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing. |
Countries
Saudi Arabia
Outcome results
None listed