Effect of Enhanced Recovery After Surgery in Reducing the Incidence of Postoperative Urinary Retention After Surgery for Benign Anorectal Conditions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 72-hours postoperative urinary retention after anorectal surgery
研究概览
简要总结
This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.
详细描述
This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.
Patients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study.
Eligible patients will be randomized in equal proportions to RRAS or ROUTINE pathways. The ERAS pathway was developed based on the available guidelines and protocols it includes 14 items.
Patients allocated to ERAS pathway must fulfill all the 14 items. The ROUTINE pathway will represent the routine practice which may include certain ERAS items or those who will not fulfill the 14 items.
For the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. However, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •both sexes
- •aged between 18 and 65 years old
- •presented with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study
排除标准
- •younger than 18
- •older than 65 years old
- •pregnant female
- •history of relevant urological diagnosis (benign prostatic hyperplasia/prostate cancer/urethral stricture/bladder neck stenosis/detrusor underactivity/detrusor overactivity)
- •history of relevant urological procedure (radical prostatectomy/ transurethral prostatectomy/bladder neck or urethral surgery/pelvic radiotherapy)
- •use of permanent urinary catheter
- •intraoperative urological procedures
- •with any form of urinary diversion
- •severe cognitive impairment
- •who undergo other anorectal procedures
研究组 & 干预措施
Enhanced recovery after surgery protocol
ERAS pathway was developed based on the available guidelines and protocols it includes 14 items
干预措施: Enhanced recovery after surgery protocol (Other)
Routine practice
This is the routine preoperative preparation
干预措施: Routine pathway (Other)
结局指标
主要结局
72-hours postoperative urinary retention after anorectal surgery
时间窗: 72 hours after surgery
the inability to void, with the patient needing bladder decompression by catheterization as determined by the treating clinician within 1 week of surgery
次要结局
未报告次要终点
研究者
Mostafa shalaby, MD, MSc, PhD
Associate Professor & Consultant Colorectal Surgery
Mansoura University