Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions
NCT ID: NCT06803550
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-17
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Enhanced recovery after surgery protocol
ERAS pathway was developed based on the available guidelines and protocols it includes 14 items
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-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
Routine practice
This is the routine preoperative preparation
Routine pathway
This is the routine preoperative preparation at our institute
Interventions
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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-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
Routine pathway
This is the routine preoperative preparation at our institute
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mostafa shalaby, MD, MSc, PhD
Associate Professor & Consultant Colorectal Surgery
Principal Investigators
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Mostafa Shalaby, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Mansoura University Hospital
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R.24.11.2877
Identifier Type: -
Identifier Source: org_study_id
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