NCT06803550

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 27, 2025

Last Update Submit

January 30, 2025

Conditions

Anal FistulaAnal Fissure ChronicHaemorrhoidEnhanced Recovery After Surgery (ERAS) Protocol

Keywords

ERASPostoperative urinary retentionBenign anorectal conditionsAnal fistulaAnal fissureHaemorrhoids

Outcome Measures

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

    72 hours after surgery

Study Arms (2)

Enhanced recovery after surgery protocol

ACTIVE COMPARATOR

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

Other: Enhanced recovery after surgery protocol

Routine practice

OTHER

This is the routine preoperative preparation

Other: Routine pathway

Interventions

Enhanced recovery after surgery protocolOTHER

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

Enhanced recovery after surgery protocol
Routine pathwayOTHER

This is the routine preoperative preparation at our institute

Routine practice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal FistulaHemorrhoidsFissure in Ano

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesAnus Diseases

Study Officials

  • Mostafa Shalaby, MD, PhD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Shalaby, MD, PhD

CONTACT

00201020555605mostafashalaby@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Consultant Colorectal Surgery

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

December 17, 2024

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)