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Recruiting NCT06803550

Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

No phase Interventional Anal Fistula Anal Fissure Chronic Haemorrhoid Enhanced Recovery After Surgery (ERAS) Protocol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced recovery after surgery protocol, Routine pathway.
Who it may be relevant to
Registry conditions: Anal Fistula, Anal Fissure Chronic, Haemorrhoid, Enhanced Recovery After Surgery (ERAS) Protocol. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Enhanced Recovery After Surgery in Reducing the Incidence of Postoperative Urinary Retention After Surgery for Benign Anorectal Conditions: a Randomized Controlled Trial

Overview

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.

Interventions

  • Other Enhanced recovery after surgery protocol
    ERAS pathway was developed based on the available guidelines and protocols it includes 14 items: 1. Preoperative patient education using an information sheet which includes instructions on postoperative wound care, pain management, and preventing and managing constipation. 2. Single preoperative enema 2 hours prior to surgery. 3. Solid or semisolid food stopped 6 hours before surgery. 4. Clear liquids may be continued up to 2 hours before surgery. 5. Preoperative carbohydrate loading in non-dia
  • Other Routine pathway
    This is the routine preoperative preparation at our institute

Primary outcome measures

  • 72-hours postoperative urinary retention after anorectal surgery [Time frame: 72 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Mansoura University Hospital — Al Mansurah

Identifiers

NCT: NCT06803550 · R.24.11.2877

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗