Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06803550

Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anal Fistula Anal Fissure Chronic Anus Diseases Cardiovascular Diseases Digestive System Diseases Digestive System Fistula Enhanced Recovery After Surgery (ERAS) Protocol Fissure in Ano Fistula Gastrointestinal Diseases Haemorrhoid Hemorrhoids Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, 35516, Egypt

Location status: Recruiting

Location contact

Mostafa Shalaby, MBBCh, MSc, MD, PhD, FACS

CONTACT

[email protected]

00201020555605

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery after surgery protocol

Other

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

  • Preoperative patient education using an information sheet which includes instructions on postoperative wound care, pain management, and preventing and managing constipation.
  • Single preoperative enema 2 hours prior to surgery.
  • Solid or semisolid food stopped 6 hours before surgery.
  • Clear liquids may be continued up to 2 hours before surgery.
  • Preoperative carbohydrate loading in non-diabetic patients for up to 2 hours prior to surgery in the form of a single 330 ml high-carbohydrate clear drink (apple juice).
  • Saddle anesthesia.
  • Single dose of intravenous 500 mg metronidazole at the time of the anaesthesi induction.
  • Restriction of intraoperative intravenous fluids to less than 500 ml.
  • Balanced chloride-restricted crystalloid solutions should be used for maintenance infusions and fluid boluses.
  • A bundle measures to reduce surgical site infection which includes

Routine pathway

Other

This is the routine preoperative preparation at our institute

Primary outcomes

  1. 72-hours postoperative urinary retention after anorectal surgery

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Shalaby, MD, PhD

CONTACT

[email protected]

00201020555605

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.