High Anal FistulaTROCO-HAFNCT07334678
TROPIS Versus Coring Out Fistulectomy in High Anal Fistula
A study testing Transanal opening of intersphincteric space (TROPIS) and Coring Out Fistulectomy in people with High Anal Fistula, run by Cairo University at 1 site in Egypt.
Trial summary
High anal fistulas represent a surgical challenge due to high recurrence rates and risk of postoperative fecal incontinence. Several sphincter-preserving techniques have been developed to address these issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Anal Fistula
- What is being tested?
- Transanal opening of intersphincteric space (TROPIS) and Coring Out Fistulectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2025to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent
Who cannot join
- Patients with fistula secondary to malignancy, inflammatory bowel disease, trauma or radiation
- Patients with Low anal fistula
- Patient with preoperative fecal incontinence
- Previous levator ani muscle injury
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
Faculty of medicine Cairo University
Cairo, Al-Manial Cairo, 11451
Ahmed Mohamed Abdelaal, Lecturer, +201118732767, drabdelaal90@gmail.com
About this study
Official title: Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial
High anal fistulas represent a surgical challenge due to high recurrence rates and risk of postoperative fecal incontinence. Several sphincter-preserving techniques have been developed to address these issues. Coring Out fistulectomy is a traditional sphincter-saving approach, while Transanal Opening of the Intersphincteric Space (TROPIS) is a recently introduced technique with promising outcomes. This randomized clinical trial aims to compare the efficacy, safety, and patient outcomes of TROPIS versus coring out fistulectomy in the management of high complex anal fistulas.
Read the detailed description
Fistula-in-ano is an abnormal epithelialized tract connecting the anal canal to the perianal skin, most commonly caused by cryptoglandular infection. High anal fistulas, involving more than one-third of the sphincter complex, carry a significant risk of postoperative incontinence when treated with fistulotomy. As a result, sphincter-preserving techniques have introduced.
Coring out fistulectomy allows excision of the fistulous tract while preserving sphincter integrity but has variable recurrence rates. TROPIS involves transanal opening of the intersphincteric space with complete preservation of the external anal sphincter and has shown high success rates in recent studies.
This prospective randomized clinical trial compares TROPIS and coring out fistulectomy regarding Failure rate (defined as failure of healing or recurrence of anal fistula), operative time, time for wound healing and postoperative complications including fecal incontinence.
- Conditions
- High Anal Fistula
- Being tested
- Transanal opening of intersphincteric space (TROPIS), Coring Out Fistulectomy
- Keywords
- TROPIS, Intersphincteric Space, Coring Out Fistulectomy, High anal fistulas, Sphincter-Preserving Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal opening of intersphincteric space (TROPIS)Procedure or surgery
The fistula tracts on both sides of the External anal sphincter (EAS) are separately dealt with. A curved artery forceps is inserted in the fistula tract in the intersphincteric space through the internal opening.The mucosa and the internal sphincter overlying the artery forceps are then incised with electrocautery. The edges of the resulting wound are trimmed and A gutter is made inferiorly from the opened-up intersphincteric space to the anal verge to facilitate drainage from the intersphincteric space wound in the postoperative period.The fistula tract lateral to (outside) the EAS will be excised till the external anal sphincter.
Coring Out FistulectomyProcedure or surgery
Incision was made around external opening.Coring out the fistulous track using a combination of cutting and coagulation diathermy from external opening to internal opening with closure of internal opening
| Study group | Role | What they receive |
|---|---|---|
| Transanal Opening of the Intersphincteric Space (TROPIS) | Experimental | patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS) Receives: Procedure: Transanal opening of intersphincteric space (TROPIS) |
| Coring Out Fistulectomy | Active comparator | patient with high anal fistula will be treated with Coring Out Fistulectomy Receives: Procedure: Coring Out Fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula (failure of healing or recurrence of anal fistula), Early results
Measured: Up to 4 months postoperatively
Secondary outcomes (9)
Operative time
compare time of operation between both procedure
Measured: During surgery
Hospitalization period
compare how many days patients stay in hospital postoperatively in both groups
Measured: From surgery until discharge
surgical site infection
compare surgical site infection in both groups
Measured: Up to 4 months postoperatively
Time for wound Healing
Time for wound Healing in both groups
Measured: Up to 4 months postoperatively
Postoperative bleeding
compare Postoperative bleeding in both groups
Measured: Up to 4 months postoperatively
postoperative fecal incontinence
compare post postoperative fecal incontinence in both groups
Measured: Up to 4 months postoperatively
Time to return to normal activity
Compare Time to return to normal activity in both groups
Measured: Up to 4 months postoperatively
Postoperative urine retention
compare postoperative urine retention in both groups
Measured: Within 48 hours postoperatively
Pain intensity
Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}).
Measured: At day 1 and day 7 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start8 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Anal FistulaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelaal, Cairo University
- Investigators
- Haitham M.Azmy Basiouny, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334678
- Sponsor's protocol ID
- MS-311-2025
- Acronym
- TROCO-HAF
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Results of Transanal Opening of the Intersphincteric Space (TROPIS) Versus Coring Out Fistulectomy in Management of High Anal Fistulas: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07334678
- Acronym / sponsor ID
- TROCO-HAF / MS-311-2025
- Conditions
- High Anal Fistula
- Keywords
- TROPIS, Intersphincteric Space, Coring Out Fistulectomy, High anal fistulas, Sphincter-Preserving Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
High anal fistulas represent a surgical challenge due to high recurrence rates and risk of postoperative fecal incontinence. Several sphincter-preserving techniques have been developed to address these issues. Coring Out fistulectomy is a traditional sphincter-saving approach, while Transanal Opening of the Intersphincteric Space (TROPIS) is a recently introduced technique with promising outcomes. This randomized clinical trial aims to compare the efficacy, safety, and patient outcomes of TROPIS versus coring out fistulectomy in the management of high complex anal fistulas.
Detailed description
Fistula-in-ano is an abnormal epithelialized tract connecting the anal canal to the perianal skin, most commonly caused by cryptoglandular infection. High anal fistulas, involving more than one-third of the sphincter complex, carry a significant risk of postoperative incontinence when treated with fistulotomy. As a result, sphincter-preserving techniques have introduced.
Coring out fistulectomy allows excision of the fistulous tract while preserving sphincter integrity but has variable recurrence rates. TROPIS involves transanal opening of the intersphincteric space with complete preservation of the external anal sphincter and has shown high success rates in recent studies.
This prospective randomized clinical trial compares TROPIS and coring out fistulectomy regarding Failure rate (defined as failure of healing or recurrence of anal fistula), operative time, time for wound healing and postoperative complications including fecal incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal Opening of the Intersphincteric Space (TROPIS) | Experimental | Procedure: Transanal opening of intersphincteric space (TROPIS)patient with high anal fistula will be treated with Transanal Opening of the Intersphincteric Space (TROPIS) |
| Coring Out Fistulectomy | Active comparator | Procedure: Coring Out Fistulectomypatient with high anal fistula will be treated with Coring Out Fistulectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with high anal fistula ( involving more than 1/3 of the sphincter complex), whether de novo or recurrent
Key exclusion criteria (4 listed)
- Patients with fistula secondary to malignancy, inflammatory bowel disease, trauma or radiation
- Patients with Low anal fistula
- Patient with preoperative fecal incontinence
- Previous levator ani muscle injury
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 |
|---|---|---|
| Transanal opening of intersphincteric space (TROPIS)The fistula tracts on both sides of the External anal sphincter (EAS) are separately dealt with. A curved artery forceps is inserted in the fistula tract in the intersphincteric space through the internal opening.The mucosa and the internal sphincter overlying the artery forceps are then incised with electrocautery. The edges of the resulting wound are trimmed and A gutter is made inferiorly from the opened-up intersphincteric space to the anal verge to facilitate drainage from the intersphincteric space wound in the postoperative period.The fistula tract lateral to (outside) the EAS will be excised till the external anal sphincter. | Procedure or surgery | Transanal Opening of the Intersphincteric Space (TROPIS) |
| Coring Out FistulectomyIncision was made around external opening.Coring out the fistulous track using a combination of cutting and coagulation diathermy from external opening to internal opening with closure of internal opening | Procedure or surgery | Coring Out Fistulectomy |
Primary outcome
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula
Time frame: Up to 4 months postoperatively
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula (failure of healing or recurrence of anal fistula), Early results
9 secondary outcomes
Operative time
Time frame: During surgery
Hospitalization period
Time frame: From surgery until discharge
surgical site infection
Time frame: Up to 4 months postoperatively
Time for wound Healing
Time frame: Up to 4 months postoperatively
Postoperative bleeding
Time frame: Up to 4 months postoperatively
postoperative fecal incontinence
Time frame: Up to 4 months postoperatively
Time to return to normal activity
Time frame: Up to 4 months postoperatively
Postoperative urine retention
Time frame: Within 48 hours postoperatively
Pain intensity
Time frame: At day 1 and day 7 postoperatively
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 27 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants
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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.
Haitham M.Azmy Basiouny, Lecturer study director
Cairo 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 Transanal opening of intersphincteric space (TROPIS) and Coring Out Fistulectomy in people with High Anal Fistula, run by Cairo 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 1 inclusion and 4 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 27 May 2026. 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 Ahmed Mohamed Abdelaal, Lecturer (+201118732767, drabdelaal90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compares Failure rate of TROPIS versus Coring Out fistulectomy in high fistula (time frame: Up to 4 months postoperatively). 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 27 May 2026.