ClinicalTrials.gg
RecruitingNCT06803550Updated Feb 3, 2025

Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

An interventional study of Enhanced recovery after surgery protocol and Routine pathway in Anal Fistula, Anal Fissure Chronic and Haemorrhoid, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Rectal Fistula by Mansoura University — 1 open to participants now, 1 under way, none of them phase 3. Rectal Fistula · Mansoura University.

Planned enrollment
2nd of 11
100 · median 66
Started
2024
the only one that year
No phase
11 of 11
1 open now
Registered
10th of 11
by date

Among the 11 studies in Rectal Fistula by Mansoura University, this one is the 2nd largest by planned enrollment, is the only one that started in 2024, is one of 11 with no phase, and was the 10th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

No phasethis study11 · 1 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2024.

Size and results

Median enrollment 66 across the 11 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 11 studies in Rectal Fistula by Mansoura University, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • ERAS
  • Postoperative urinary retention
  • Benign anorectal conditions
  • Anal fistula
  • Anal fissure
  • Haemorrhoids
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Enhanced recovery after surgery protocol

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

    Other: Enhanced recovery after surgery protocol

  • Other
    Routine practice

    This is the routine preoperative preparation

    Other: Routine pathway

Interventions

  • OtherEnhanced 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-diabetic patients for up to 2 hours prior to surgery in the form of a single 330 ml high-carbohydrate clear drink (apple juice). 6. Saddle anesthesia. 7. Single dose of intravenous 500 mg metronidazole at the time of the anaesthesi induction. 8. Restriction of intraoperative intravenous fluids to less than 500 ml. 9. Balanced chloride-restricted crystalloid solutions should be used for maintenance infusions and fluid boluses. 10. A bundle measures to reduce surgical site infection which includes

  • OtherRoutine pathway

    This is the routine preoperative preparation at our institute

06

What researchers measure

Primary outcomes

  1. 72-hours postoperative urinary retention after anorectal surgery

    the inability to void, with the patient needing bladder decompression by catheterization as determined by the treating clinician within 1 week of surgery

    Time frame: 72 hours after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06803550
Responsible party
Mostafa shalaby, MD, MSc, PhD (Associate Professor & Consultant Colorectal Surgery, Mansoura University) — Principal investigator
First posted
Jan 31, 2025
Start date
Dec 17, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Feb 3, 2025

Study contacts

Mostafa Shalaby, MD, PhD
Contact
mostafashalaby@mans.edu.eg
00201020555605
Mostafa Shalaby, MD, PhD
principal investigator · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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