Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

Mansoura University

Status: Enrolling

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

Treatments: Other: Enhanced recovery after surgery protocol; Other: Routine pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT06803550

R.24.11.2877

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Enhanced recovery after surgery protocol

Active Comparator group

Description:

ERAS pathway was developed based on the available guidelines and protocols it includes 14 items

Treatment:

Other: Enhanced recovery after surgery protocol

Routine practice

Other group

Description:

This is the routine preoperative preparation

Treatment:

Other: Routine pathway