Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Urinary retention
研究概览
简要总结
This is a prospective, comparative randomized study. Our study population includes women with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.
The two groups will include the study group, who will have their Foley catheter removed 6 hours post-op, and the control group who will have an indwelling Foley catheter overnight. The two groups will be assigned according REDCap randomization system.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 19-75
- •Pelvic organ prolapse requiring robotic assisted, laparoscopic sacrocolpopexy.
排除标准
- •Intraoperative complications necessitating a post-operative Foley
- •Cystotomy
- •EBL >500mL
- •Bowl injury
- •Pre-operative urinary retention requiring an indwelling catheter
研究组 & 干预措施
Foley
Patients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution.
No Foley
Patients will have Foley catheter removed 6 hours post-op.
干预措施: No Foley (Other)
结局指标
主要结局
Urinary retention
时间窗: 6 hours after discharge from PACU
Patients in the intervention group will have their Foley catheter removed up to 6 hours after discharge from the PCA. They will then have to undergo a voiding trial
次要结局
- Urinary Tract Infections(30 day post op)
- Post-operative complications(30 days post op)