Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,554
- 试验地点
- 1
- 主要终点
- Readmission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Body mass index <60
- •American Anesthesiologists Association classification ≤III
- •Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery
排除标准
- •High risk for thromboembolic disease
- •Has a history of major open abdominal surgery
- •Bleeding disorders
- •Heart disease
- •Pulmonary hypertension
- •Uncontrolled type 2 diabetes
- •Severe obstructive sleep apnea
- •Chronic obstructive pulmonary disease
结局指标
主要结局
Readmission
时间窗: up to 12 months after surgery
Readmission to hospital after discharge
Number of patients undergoing reoperative or revisional surgical or endoscopic intervention
时间窗: up to 12 months
Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications
Hospital Transfer
时间窗: up to 16 hours
Transfer of patient in Ambulatory LSG group to hospital for postop stay
Mortality
时间窗: up to 30 days
Postoperative 30-day mortality rate
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
时间窗: within 30 days
Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)
次要结局
- Weight loss(3 months, 6 months, and 1 year)
研究者
Aayed Alqahtani
Professor of Surgery
King Saud University