Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

Not Applicable

Recruiting

• Conditions: Anal Fistula; Anal Fissure Chronic; Haemorrhoid; Enhanced Recovery After Surgery (ERAS) Protocol

• Registration Number: NCT06803550
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

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.

The primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery.

Study Timeline

• Study Start: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
72-hours postoperative urinary retention after anorectal surgery	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

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt