Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- PACU Time
研究概览
简要总结
The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.
详细描述
This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision
排除标准
- •Age < 18 yo or > 80 yo
- •Prisoners
- •Pregnant Women
- •Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
研究组 & 干预措施
SOC Voiding Protocol
Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home.
No Void Intervention
Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
干预措施: No Void (Other)
结局指标
主要结局
PACU Time
时间窗: This measure will be recorded through the study period.
This is the time patients in each arm spend in recovery. Measured as minutes elapsed between the end of surgery (surgery end time) and discharge from recovery room.
次要结局
- 30-day Readmission(30 days)
研究者
Syed Husain
Assistant Professor - Colon and Rectal Surgery
Ohio State University