Anal FistulaNCT06803550
Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions
A study testing Enhanced recovery after surgery protocol and Routine pathway in people with Anal Fistula and Anal Fissure Chronic, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula, Anal Fissure Chronic, Haemorrhoid
- What is being tested?
- Enhanced recovery after surgery protocol and Routine pathway
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- intraoperative urological procedures
- with any form of urinary diversion
- severe cognitive impairment
- who undergo other anorectal procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, 35516
Mostafa Shalaby, MBBCh, MSc, MD, PhD, FACS, 00201020555605, mostafashalaby@mans.edu.eg
About this study
Official 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
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.
- Conditions
- Anal Fistula, Anal Fissure Chronic, Haemorrhoid, Enhanced Recovery After Surgery (ERAS) Protocol
- Being tested
- Enhanced recovery after surgery protocol, Routine pathway
- Keywords
- ERAS, Postoperative urinary retention, Benign anorectal conditions, Anal fistula, Anal fissure, Haemorrhoids
- Medical subject headings
- Rectal Fistula, Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery protocolOther
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 pathwayOther
This is the routine preoperative preparation at our institute
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery after surgery protocol | Active comparator | ERAS pathway was developed based on the available guidelines and protocols it includes 14 items Receives: Other: Enhanced recovery after surgery protocol |
| Routine practice | Other | This is the routine preoperative preparation Receives: Other: Routine pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start17 Dec 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, MD, PhD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803550
- Sponsor's protocol ID
- R.24.11.2877
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06803550
- Acronym / sponsor ID
- R.24.11.2877
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery after surgery protocol | Active comparator | Other: Enhanced recovery after surgery protocolERAS pathway was developed based on the available guidelines and protocols it includes 14 items |
| Routine practice | Other | Other: Routine pathwayThis is the routine preoperative preparation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgery protocolERAS 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 | Other | Enhanced recovery after surgery protocol |
| Routine pathwayThis is the routine preoperative preparation at our institute | Other | Routine practice |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Shalaby, MD, PhD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surgery protocol and Routine pathway in people with Anal Fistula and Anal Fissure Chronic, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Shalaby, MD, PhD (00201020555605, mostafashalaby@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
72-hours postoperative urinary retention after anorectal surgery (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.