High Transsphincteric Perianal FistulaNCT07744672
Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula
A study testing Cyanoacrylate adhesive (Glubran 2) and ligation of the intersphincteric fistula tract in people with High Transsphincteric Perianal Fistula, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- High Transsphincteric Perianal Fistula
- What is being tested?
- Cyanoacrylate adhesive (Glubran 2) and ligation of the intersphincteric fistula tract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 20 Apr 2027
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)
Who cannot join
- Crohn's disease
- Tuberculosis or malignancy-associated fistula
- Horseshoe fistula
- Previous definitive fistula surgery (excluding drainage procedures)
- Pregnancy
- Immunocompromised state (e.g., HIV, chronic steroid use, chemotherapy)
- Uncontrolled diabetes mellitus (HbA1c > 8% )
- Active, undrained perianal sepsis/abscess at the time of scheduled surgery
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 Ain Shams University
Cairo
About this study
Official title: Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
Read the detailed description
This study is a prospective randomized controlled trial comparing ligation of the intersphincteric fistula tract (LIFT) with cyanoacrylate glue (CAG) in the treatment of high transsphincteric perianal fistula.
Adult patients with MRI-confirmed disease will be randomly assigned in a 1:1 ratio to either technique.
The primary outcome is fistula healing , while secondary outcomes include operative time, postoperative pain, complications, recurrence, and continence.
This trial aims to determine the safer and more effective sphincter-preserving approach.
- Conditions
- High Transsphincteric Perianal Fistula
- Being tested
- Cyanoacrylate adhesive (Glubran 2), ligation of the intersphincteric fistula tract
- Keywords
- LIFT, ligation of intersphincteric fistulous tract, CAG, cyanoacrylate glue, perianal fistula, rondomized controlled trial, sphincter perserving surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate adhesive (Glubran 2)Procedure or surgery
Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing.
ligation of the intersphincteric fistula tractProcedure or surgery
Patients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula.
| Study group | Role | What they receive |
|---|---|---|
| Ligation of the intersphincteric fistula tract | Active comparator | Patients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula. Receives: Procedure: ligation of the intersphincteric fistula tract |
| Cyanoacrylate Glue (Glubran 2) | Experimental | cyanoacrylate glue (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote subsequent fistula healing Receives: Procedure: Cyanoacrylate adhesive (Glubran 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Fistula Healing Rate
Complete epithelialization of the external opening, confirmed clinically and, where indicated, by MRI, with no discharge on gentle compression and no evidence of abscess or infection.
Measured: 3 months post-operative
Secondary outcomes (5)
Fistula Recurrence Rate
Reappearance of discharge, abscess, or fistula tract confirmed clinically and/or by MRI after documented initial healing
Measured: Up to 12 months post-operative
Change in Fecal Continence
Change in continence status from baseline using Cleveland Clinic Florida Fecal Incontinence Score (Wexner Score) 0-20 , range 0 [perfect continence] to 20 [complete incontinence]; higher score = worse continence)
Measured: up to 12 months post-operative
Postoperative Wound Infection Rate
Clinical signs of infection (erythema, purulent discharge, fever) requiring antibiotic treatment or drainage
Measured: Within 1 month post-operative
Postoperative Pain Intensity (Visual Analog Scale)
Self-reported pain intensity will be assessed using the 10-point Visual Analog Scale, where 0 = no pain and 10 = worst pain.
Measured: 24 hours , 1 week and 2 weeks Postoperative
Total Operative Time
Operative time is defined as the time from initial surgical incision or fistula tract access to completion of the procedure, including tract ligation in the LIFT group and complete cyanoacrylate glue instillation in the cyanoacrylate group.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Sep 2025
- Primary completion14 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Transsphincteric Perianal FistulaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744672
- Sponsor's protocol ID
- FMASUGSMD148-9-2025
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for all participants will be shared, including information used to assess the main outcome (fistula healing) and secondary outcomes (operative time, pain after surgery, wound infection, recurrence, and continence score), along with basic demographic and clinical data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07744672
- Acronym / sponsor ID
- FMASUGSMD148-9-2025
- Conditions
- High Transsphincteric Perianal Fistula
- Keywords
- LIFT, ligation of intersphincteric fistulous tract, CAG, cyanoacrylate glue, perianal fistula, rondomized controlled trial, sphincter perserving surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 4 Aug 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.
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
Detailed description
This study is a prospective randomized controlled trial comparing ligation of the intersphincteric fistula tract (LIFT) with cyanoacrylate glue (CAG) in the treatment of high transsphincteric perianal fistula.
Adult patients with MRI-confirmed disease will be randomly assigned in a 1:1 ratio to either technique.
The primary outcome is fistula healing , while secondary outcomes include operative time, postoperative pain, complications, recurrence, and continence.
This trial aims to determine the safer and more effective sphincter-preserving approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligation of the intersphincteric fistula tract | Active comparator | Procedure: ligation of the intersphincteric fistula tractPatients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula. |
| Cyanoacrylate Glue (Glubran 2) | Experimental | Procedure: Cyanoacrylate adhesive (Glubran 2)cyanoacrylate glue (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote subsequent fistula healing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)
Key exclusion criteria (8 listed)
- Crohn's disease
- Tuberculosis or malignancy-associated fistula
- Horseshoe fistula
- Previous definitive fistula surgery (excluding drainage procedures)
- Pregnancy
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 |
|---|---|---|
| Cyanoacrylate adhesive (Glubran 2)Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing. | Procedure or surgery | Cyanoacrylate Glue (Glubran 2) |
| ligation of the intersphincteric fistula tractPatients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula. | Procedure or surgery | Ligation of the intersphincteric fistula tract |
Primary outcome
Complete Fistula Healing Rate
Time frame: 3 months post-operative
Complete epithelialization of the external opening, confirmed clinically and, where indicated, by MRI, with no discharge on gentle compression and no evidence of abscess or infection.
5 secondary outcomes
Fistula Recurrence Rate
Time frame: Up to 12 months post-operative
Change in Fecal Continence
Time frame: up to 12 months post-operative
Postoperative Wound Infection Rate
Time frame: Within 1 month post-operative
Postoperative Pain Intensity (Visual Analog Scale)
Time frame: 24 hours , 1 week and 2 weeks Postoperative
Total Operative Time
Time frame: Intraoperative
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data for all participants will be shared, including information used to assess the main outcome (fistula healing) and secondary outcomes (operative time, pain after surgery, wound infection, recurrence, and continence score), along with basic demographic and clinical data.
Related trials for High Transsphincteric Perianal Fistula
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Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanoacrylate adhesive (Glubran 2) and ligation of the intersphincteric fistula tract in people with High Transsphincteric Perianal Fistula, run by Ain Shams 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 8 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 4 Aug 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 mohamed Ibrahim khald, Assistant lecturer (+201061399219, mohamed.khald@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Fistula Healing Rate (time frame: 3 months post-operative). 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 4 Aug 2026.