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Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06803550
Enrollment
100
Registered
2025-01-31
Start date
2024-12-17
Completion date
2025-06-30
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
72-hours postoperative urinary retention after anorectal surgery72 hours after surgerythe inability to void, with the patient needing bladder decompression by catheterization as determined by the treating clinician within 1 week of surgery

Countries

Egypt

Contacts

Primary ContactMostafa Shalaby, MD, PhD
mostafashalaby@mans.edu.eg00201020555605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026