Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Acute urinary retention rate
研究概览
简要总结
The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.
The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
patients and surgeons are blinded to group allocation until the end of surgical procedure
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 80 years old
- •Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
- •Willingness to participate
- •Compliance to study purpose
- •Written informed consent
排除标准
- •Need for an anastomosis below the anterior peritoneal reflection
- •Need for a major resection other than colorectal
- •Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
- •Anesthesia time longer than 300 minutes
- •Presence of chronic indwelling UC
- •Presence of an entero-vesical fistula
- •Need for ureteral stent placement, bladder resection or repair
- •A previous and unsolved history of AUR or overt voiding dysfunction
结局指标
主要结局
Acute urinary retention rate
时间窗: 3 days postoperatively
Occurrence of urinary retention after removal of urinary catheter
次要结局
- Urinary tract infections(30 days postoperatively)
- UC reinsertion(30 days postoperatively)
- Pain scores(6,12,24,48 and 72 hours after surgery)
- Bowel function(10 days postoperatively)
- Mobilization(10 days postoperatively)
- Length of hospital stay(30 days postoperatively)
- Morbility(first 30 days after surgery)