Anal FistulaNCT05476146
Re-routing in Treatment High Anal Fistula
A study testing Rerouting of the track in high anal fitula in people with Anal Fistula, run by Assiut University.
Trial summary
The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Rerouting of the track in high anal fitula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria:- patients with high anal fistula admitted at Asuit University Hospital at the period of study
Exclusion Criteria:- Any case with low anal fistula
About this study
Official title: Re-routing of the Track in the Treatment of High Anal Fistula
The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?
Read the detailed description
Anal fistula is a very common perianal condition associated with considerable morbidity and inconvenience to the patient. It is hollow tract lined with granulation tissue that connects an in-depth primary opening inside the anal canal to a superficial secondary opening in the perianal skin. It is mostly nonspecific infection of an anal gland in the intersphincteric space as the initiating pathology Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy into intersphincteric, trans-sphincteric, and supra-sphincteric or extra-sphincteric Surgical therapy is the main method used to treat anal fistula. The best treatment criterion is to eradicate the infected lesion, ensure sufficient drainage, and promote the closure of the fistula, while minimizing damage to the anal sphincter.
High anal fistulas require more complex treatment when compared to low anal fistula because of their complexity.
Rerouting is a transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. The newly posi-tioned intersphincteric fistula is then dealt with at a later date when the external sphincter is soundly healed .
The advantages of rerouting over other techniques in patients with high anal fistulae; patients had satisfactory results, decrease recurrence of fistulae or abscess formation. Healing is rapid, short hospital stay and continence to flatus and faeces preserved
- Conditions
- Anal Fistula
- Being tested
- Rerouting of the track in high anal fitula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rerouting of the track in high anal fitulaProcedure or surgery
Treatment of high anal fistula by rerouting
| Study group | Role | What they receive |
|---|---|---|
| Rerouting of track of high anal fistula | Experimental | Not described Receives: Procedure: Rerouting of the track in high anal fitula |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation the role of rerouting of the track in high anal fistula in treatemt
: collect result and see recurance and incontinence rate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Mohamed Abdelghany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476146
- Sponsor's protocol ID
- AssutU
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shehata MR, Abdelghany MMM, Eid GAA, Hanna RS. Rerouting of the tract in the treatment of high anal fistula: a single-center experience. Tech Coloproctol. 2025 Jul 24;29(1):150. doi: 10.1007/s10151-025-03179-3.
PubMed 40707706
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-routing of the Track in the Treatment of High Anal Fistula
- ClinicalTrials.gov ID
- NCT05476146
- Acronym / sponsor ID
- AssutU
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?
Detailed description
Anal fistula is a very common perianal condition associated with considerable morbidity and inconvenience to the patient. It is hollow tract lined with granulation tissue that connects an in-depth primary opening inside the anal canal to a superficial secondary opening in the perianal skin. It is mostly nonspecific infection of an anal gland in the intersphincteric space as the initiating pathology Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy into intersphincteric, trans-sphincteric, and supra-sphincteric or extra-sphincteric Surgical therapy is the main method used to treat anal fistula. The best treatment criterion is to eradicate the infected lesion, ensure sufficient drainage, and promote the closure of the fistula, while minimizing damage to the anal sphincter.
High anal fistulas require more complex treatment when compared to low anal fistula because of their complexity.
Rerouting is a transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. The newly posi-tioned intersphincteric fistula is then dealt with at a later date when the external sphincter is soundly healed .
The advantages of rerouting over other techniques in patients with high anal fistulae; patients had satisfactory results, decrease recurrence of fistulae or abscess formation. Healing is rapid, short hospital stay and continence to flatus and faeces preserved
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rerouting of track of high anal fistula | Experimental | Procedure: Rerouting of the track in high anal fitula |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Rerouting of the track in high anal fitulaTreatment of high anal fistula by rerouting | Procedure or surgery | Rerouting of track of high anal fistula |
Primary outcome
evaluation the role of rerouting of the track in high anal fistula in treatemt
Time frame: 6 months
: collect result and see recurance and incontinence rate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 40707706Shehata MR, Abdelghany MMM, Eid GAA, Hanna RS. Rerouting of the tract in the treatment of high anal fistula: a single-center experience. Tech Coloproctol. 2025 Jul 24;29(1):150. doi: 10.1007/s10151-025-03179-3.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rerouting of the track in high anal fitula in people with Anal Fistula, run by Assiut University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation the role of rerouting of the track in high anal fistula in treatemt (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476146, which also lists 1 linked publication.
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 23 Aug 2022.