Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula

August 2, 2026 updated by: Ain Shams University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of medicine ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ligation of the intersphincteric fistula tract
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.
Procedure: ligation of the intersphincteric fistula tract
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.
Experimental: Cyanoacrylate Glue (Glubran 2)
cyanoacrylate glue (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote subsequent fistula healing
Procedure: Cyanoacrylate adhesive (Glubran 2)
Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fistula Recurrence Rate
Time Frame: Up to 12 months post-operative
Reappearance of discharge, abscess, or fistula tract confirmed clinically and/or by MRI after documented initial healing
Up to 12 months post-operative
Change in Fecal Continence
Time Frame: up to 12 months post-operative
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)
up to 12 months post-operative
Postoperative Wound Infection Rate
Time Frame: Within 1 month post-operative
Clinical signs of infection (erythema, purulent discharge, fever) requiring antibiotic treatment or drainage
Within 1 month post-operative
Postoperative Pain Intensity (Visual Analog Scale)
Time Frame: 24 hours , 1 week and 2 weeks Postoperative
Self-reported pain intensity will be assessed using the 10-point Visual Analog Scale, where 0 = no pain and 10 = worst pain.
24 hours , 1 week and 2 weeks Postoperative
Total Operative Time
Time Frame: Intraoperative
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.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASUGSMD148-9-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary results and will remain accessible for up to 3 years thereafter.

IPD Sharing Access Criteria

Access will be granted to qualified researchers who submit a methodologically sound proposal, upon signing a data access/use agreement with the corresponding author. Requests will be reviewed on a case-by-case basis and require approval from the Institutional Ethics Committee, Ain Shams University, prior to data release.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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