High Perianal FistulaNCT07399353
Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula
A study testing Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract in people with High Perianal Fistula, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- High Perianal Fistula
- What is being tested?
- Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2025to 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 20-65 years) presenting with a high perianal fistula, defined as:Trans-sphincteric fistula tract traversing the upper two-thirds of the external anal sphincter, Or Extrasphincteric fistula.
- Patients with recurrent perianal fistula.
- Ability to provide informed consent.
Who cannot join
- Patients with preoperative fecal incontinence (as assessed by the Cleveland Clinic Fecal Incontinence Score).
- Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Pregnant women.
- Pediatric patients (age < 20 years).
- Patients with complex, branching fistula tracts.
- Any contraindication to spinal/general anesthesia or 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 Cairo University
Cairo, Al-Manial Cairo, 11956
Refaei, Assistant professor, +201012400838, Osama.ref.m@gmail.com
About this study
Official title: Comparative Study Between Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract (LIFT) Technique in Treatment of High Perianal Fistula.
The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. The main questions the study aims to answer are:
Which surgery has a lower chance of the fistula coming back (recurrence)?
Read more
Which surgery has a lower chance of causing problems with bowel control (incontinence) after healing?
Researchers will compare two surgery groups:
Group 1: Fistula Rerouting Technique - a two-step surgery that moves the fistula tract to a safer area before opening it.
Group 2: LIFT Technique - a surgery that ties off and closes the fistula tract from between the anal muscles.
Participants will be randomly assigned by a computer to one of these two surgery groups. This helps ensure the comparison between the two surgeries is fair.
Participants in this study will:
- Have tests before surgery, including an MRI scan, to confirm they have the specific type of fistula being studied.
- Undergo one of the two planned surgical procedures.
- Attend follow-up visits after surgery at 1 week, 2 weeks, 1 month, and 3 months.
- Be checked during these visits for wound healing, pain, infection, and bowel control.
- Have another MRI scan if the fistula is suspected to have come back.
Read the detailed description
This study is a prospective, randomized, controlled, parallel-group surgical trial designed to evaluate and compare the efficacy and functional outcomes of two sphincter-preserving techniques for the management of high perianal fistula: the staged Fistula Rerouting Technique (FRT) and the Ligation of Intersphincteric Fistula Tract (LIFT) procedure.
Background and Rationale:
High perianal fistulas, particularly trans-sphincteric and extrasphincteric types, pose a significant surgical challenge. Traditional fistulotomy carries a high risk of postoperative fecal incontinence due to the division of a substantial portion of the anal sphincter complex. Consequently, sphincter-preserving techniques have been developed. The LIFT procedure, introduced in 2007, achieves closure of the fistula tract via an intersphincteric approach. The FRT, described earlier, employs a staged strategy to physically transpose the fistula tract to a safer intersphincteric plane before its division. While both techniques aim to eradicate the fistula while minimizing injury to the continence mechanism, direct comparative evidence regarding their relative effectiveness, recurrence rates, and impact on postoperative continence is lacking in the literature. This trial aims to fill this evidence gap.
Objectives:
The primary objective is to compare the postoperative recurrence rate of high perianal fistula between the FRT and LIFT groups. The secondary objective is to compare the rate of postoperative fecal incontinence between the two techniques. Additional outcomes include time to wound healing, incidence of surgical site infection, postoperative pain scores, patient-reported quality of life related to incontinence, and time to return to normal activities.
Methodology Overview:
Eligible adult patients (aged 20-65 years) diagnosed with a high perianal fistula at Kasr-Alainy Teaching Hospital will be enrolled. Key exclusion criteria include preoperative incontinence, inflammatory bowel disease, and complex branching fistulas. After providing informed consent, participants will undergo preoperative assessment including clinical examination, MRI fistulogram for tract mapping, and baseline continence scoring using the Cleveland Clinic Fecal Incontinence Score (CCFIS).
Participants will be randomly allocated in a 1:1 ratio to either the FRT group or the LIFT group using a computer-generated randomization sequence with allocation concealment.
FRT Group: Participants will undergo the two-stage procedure as described. The second-stage fistulotomy will be performed only after complete healing of the first-stage wound.
LIFT Group: Participants will undergo the single-stage LIFT procedure.
All surgeries will be performed by experienced colorectal surgeons. A standardized postoperative care and follow-up regimen will be applied to all participants, with scheduled assessments at 1 week, 2 weeks, 1 month, 3 months postoperatively. These assessments will include clinical evaluation for recurrence, wound inspection, CCFIS scoring, patient-reported outcome measures, and documentation of any complications or re-interventions. A follow-up MRI will be performed if clinical recurrence is suspected.
Statistical Considerations:
A sample size of 20 patients per group (40 total) has been calculated based on estimates of recurrence rates for high fistulas. Data will be analyzed on an intention-to-treat basis. The findings of this study are expected to provide Level I evidence to help guide surgical decision-making for this complex condition, balancing the goals of fistula eradication and functional preservation.
- Conditions
- High Perianal Fistula
- Being tested
- Fistula Rerouting Technique, Ligation of Intersphincteric Fistula Tract
- Keywords
- Fistula rerouting, LIFT (Ligation of Intersphincteric Fistula Tract), High perianal fistula, Anal fistula surgery, Sphincter-saving surgery, Fecal incontinence, Randomized controlled trial
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistula Rerouting TechniqueProcedure or surgery
A two-stage, sphincter-preserving surgical procedure for high perianal fistula. Stage 1: The native fistulous tract is surgically dissected and transposed from its trans-sphincteric course into the intersphincteric plane. The defect in the external sphincter is repaired. Stage 2: After complete healing of the first-stage wound, a fistulotomy is performed on the newly created intersphincteric tract. The goal is to eradicate the fistula while minimizing injury to the anal sphincter complex.
Ligation of Intersphincteric Fistula TractProcedure or surgery
A single-stage, sphincter-preserving surgical procedure for perianal fistula. The fistula tract is accessed via an incision in the intersphincteric groove. The tract is identified, dissected, divided, and both ends are ligated. The infected cryptoglandular tissue is excised. The internal and external wounds are debrided and left open to heal by secondary intention. The goal is to close the fistula tract at its origin while preserving sphincter function.
| Study group | Role | What they receive |
|---|---|---|
| Fistula Rerouting Technique Group | Experimental | Participants in this group will undergo a staged Fistula Rerouting procedure. First Stage: The fistulous tract is cored out using diathermy. Dissection is continued until the point where the tract traverses the external anal sphincter. A circumanal incision is made at the anal verge over this point. The intersphincteric space is entered and dissected until the fistulous tract is palpable. The tract is then dissected off the external sphincter via muscle-splitting and transposed into the intersphincteric space. The original defect in the external sphincter is closed with interrupted absorbable sutures. If the transposed tract is too long, its distal portion is excised. A seton may be placed in the new intersphincteric tract to mark it for the second stage, provided this does not risk injury to the mobilized tract.
Second Stage: After complete healing of the first-stage wound (typically several weeks later), a fistulotomy is performed on the new, transposed intersphincteric tract Receives: Procedure: Fistula Rerouting Technique |
| LIFT Technique Group | Experimental | Participants in this group will undergo the Ligation of Intersphincteric Fistula Tract (LIFT) procedure.
A curvilinear incision is then made in the intersphincteric groove (the groove between the internal and external anal sphincters) overlying the identified tract.
Dissection proceeds through the intersphincteric plane until the mature, fibrous fistula tract is encountered. The tract is carefully isolated, then divided. Both the internal (toward the anal canal) and external (toward the skin) ends of the divided tract are securely ligated (tied off) with suture material. The infected cryptoglandular tissue surrounding the tract is debrided and removed.
The internal wound (near the anal canal) and the external wound (in the intersphincteric groove) are debrided and left open to heal by secondary intention, ensuring adequate drainage. Receives: Procedure: Ligation of Intersphincteric Fistula Tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Recurrence Rate
The proportion of patients in each group with clinically confirmed recurrence of the perianal fistula within 6 months postoperatively. Recurrence is defined as the reappearance of symptoms (pain, discharge) and/or a confirmed tract on postoperative MRI fistulogram.
Measured: Within 3 months after the final surgical procedure
Postoperative Fecal Incontinence
Change in anal continence status assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS). The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates worse function. Incontinence is defined as a CCFIS ≥ 5.
Measured: At 3 months postoperatively
Secondary outcomes (3)
Time to Complete Wound Healing
The number of days required for the surgical wound to heal completely, defined as full epithelialization with no discharge
Measured: From the date of surgery until the date of documented complete healing, assessed up to 3 months
Postoperative Wound Infection Rate
The proportion of patients in each group developing surgical site infection, defined by the presence of purulent discharge, erythema, warmth, or tenderness requiring antibiotic treatment or intervention.
Measured: Within 6 weeks postoperatively
Postoperative Pain
Patient-reported pain intensity assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: At 1 week and 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start28 Aug 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Perianal 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Sedky Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399353
- Sponsor's protocol ID
- MS-312-2025
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract (LIFT) Technique in Treatment of High Perianal Fistula.
- ClinicalTrials.gov ID
- NCT07399353
- Acronym / sponsor ID
- MS-312-2025
- Conditions
- High Perianal Fistula
- Keywords
- Fistula rerouting, LIFT (Ligation of Intersphincteric Fistula Tract), High perianal fistula, Anal fistula surgery, Sphincter-saving surgery, Fecal incontinence, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Feb 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.
The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. The main questions the study aims to answer are:
Which surgery has a lower chance of the fistula coming back (recurrence)?
Which surgery has a lower chance of causing problems with bowel control (incontinence) after healing?
Researchers will compare two surgery groups:
Group 1: Fistula Rerouting Technique - a two-step surgery that moves the fistula tract to a safer area before opening it.
Group 2: LIFT Technique - a surgery that ties off and closes the fistula tract from between the anal muscles.
Participants will be randomly assigned by a computer to one of these two surgery groups. This helps ensure the comparison between the two surgeries is fair.
Participants in this study will:
- Have tests before surgery, including an MRI scan, to confirm they have the specific type of fistula being studied.
- Undergo one of the two planned surgical procedures.
- Attend follow-up visits after surgery at 1 week, 2 weeks, 1 month, and 3 months.
- Be checked during these visits for wound healing, pain, infection, and bowel control.
- Have another MRI scan if the fistula is suspected to have come back.
Detailed description
This study is a prospective, randomized, controlled, parallel-group surgical trial designed to evaluate and compare the efficacy and functional outcomes of two sphincter-preserving techniques for the management of high perianal fistula: the staged Fistula Rerouting Technique (FRT) and the Ligation of Intersphincteric Fistula Tract (LIFT) procedure.
Background and Rationale:
High perianal fistulas, particularly trans-sphincteric and extrasphincteric types, pose a significant surgical challenge. Traditional fistulotomy carries a high risk of postoperative fecal incontinence due to the division of a substantial portion of the anal sphincter complex. Consequently, sphincter-preserving techniques have been developed. The LIFT procedure, introduced in 2007, achieves closure of the fistula tract via an intersphincteric approach. The FRT, described earlier, employs a staged strategy to physically transpose the fistula tract to a safer intersphincteric plane before its division. While both techniques aim to eradicate the fistula while minimizing injury to the continence mechanism, direct comparative evidence regarding their relative effectiveness, recurrence rates, and impact on postoperative continence is lacking in the literature. This trial aims to fill this evidence gap.
Objectives:
The primary objective is to compare the postoperative recurrence rate of high perianal fistula between the FRT and LIFT groups. The secondary objective is to compare the rate of postoperative fecal incontinence between the two techniques. Additional outcomes include time to wound healing, incidence of surgical site infection, postoperative pain scores, patient-reported quality of life related to incontinence, and time to return to normal activities.
Methodology Overview:
Eligible adult patients (aged 20-65 years) diagnosed with a high perianal fistula at Kasr-Alainy Teaching Hospital will be enrolled. Key exclusion criteria include preoperative incontinence, inflammatory bowel disease, and complex branching fistulas. After providing informed consent, participants will undergo preoperative assessment including clinical examination, MRI fistulogram for tract mapping, and baseline continence scoring using the Cleveland Clinic Fecal Incontinence Score (CCFIS).
Participants will be randomly allocated in a 1:1 ratio to either the FRT group or the LIFT group using a computer-generated randomization sequence with allocation concealment.
FRT Group: Participants will undergo the two-stage procedure as described. The second-stage fistulotomy will be performed only after complete healing of the first-stage wound.
LIFT Group: Participants will undergo the single-stage LIFT procedure.
All surgeries will be performed by experienced colorectal surgeons. A standardized postoperative care and follow-up regimen will be applied to all participants, with scheduled assessments at 1 week, 2 weeks, 1 month, 3 months postoperatively. These assessments will include clinical evaluation for recurrence, wound inspection, CCFIS scoring, patient-reported outcome measures, and documentation of any complications or re-interventions. A follow-up MRI will be performed if clinical recurrence is suspected.
Statistical Considerations:
A sample size of 20 patients per group (40 total) has been calculated based on estimates of recurrence rates for high fistulas. Data will be analyzed on an intention-to-treat basis. The findings of this study are expected to provide Level I evidence to help guide surgical decision-making for this complex condition, balancing the goals of fistula eradication and functional preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fistula Rerouting Technique Group | Experimental | Procedure: Fistula Rerouting TechniqueParticipants in this group will undergo a staged Fistula Rerouting procedure. First Stage: The fistulous tract is cored out using diathermy. Dissection is continued until the point where the tract traverses the external anal sphincter. A circumanal incision is made at the anal verge over this point. The intersphincteric space is entered and dissected until the fistulous tract is palpable. The tract is then dissected off the external sphincter via muscle-splitting and transposed into the intersphincteric space. The original defect in the external sphincter is closed with interrupted absorbable sutures. If the transposed tract is too long, its distal portion is excised. A seton may be placed in the new intersphincteric tract to mark it for the second stage, provided this does not risk injury to the mobilized tract. Second Stage: After complete healing of the first-stage wound (typically several weeks later), a fistulotomy is performed on the new, transposed intersphincteric tract |
| LIFT Technique Group | Experimental | Procedure: Ligation of Intersphincteric Fistula TractParticipants in this group will undergo the Ligation of Intersphincteric Fistula Tract (LIFT) procedure. A curvilinear incision is then made in the intersphincteric groove (the groove between the internal and external anal sphincters) overlying the identified tract. Dissection proceeds through the intersphincteric plane until the mature, fibrous fistula tract is encountered. The tract is carefully isolated, then divided. Both the internal (toward the anal canal) and external (toward the skin) ends of the divided tract are securely ligated (tied off) with suture material. The infected cryptoglandular tissue surrounding the tract is debrided and removed. The internal wound (near the anal canal) and the external wound (in the intersphincteric groove) are debrided and left open to heal by secondary intention, ensuring adequate drainage. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age 20-65 years) presenting with a high perianal fistula, defined as:Trans-sphincteric fistula tract traversing the upper two-thirds of the external anal sphincter, Or Extrasphincteric fistula.
- Patients with recurrent perianal fistula.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- Patients with preoperative fecal incontinence (as assessed by the Cleveland Clinic Fecal Incontinence Score).
- Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Pregnant women.
- Pediatric patients (age < 20 years).
- Patients with complex, branching fistula tracts.
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 |
|---|---|---|
| Fistula Rerouting TechniqueA two-stage, sphincter-preserving surgical procedure for high perianal fistula. Stage 1: The native fistulous tract is surgically dissected and transposed from its trans-sphincteric course into the intersphincteric plane. The defect in the external sphincter is repaired. Stage 2: After complete healing of the first-stage wound, a fistulotomy is performed on the newly created intersphincteric tract. The goal is to eradicate the fistula while minimizing injury to the anal sphincter complex. | Procedure or surgery | Fistula Rerouting Technique Group |
| Ligation of Intersphincteric Fistula TractA single-stage, sphincter-preserving surgical procedure for perianal fistula. The fistula tract is accessed via an incision in the intersphincteric groove. The tract is identified, dissected, divided, and both ends are ligated. The infected cryptoglandular tissue is excised. The internal and external wounds are debrided and left open to heal by secondary intention. The goal is to close the fistula tract at its origin while preserving sphincter function. | Procedure or surgery | LIFT Technique Group |
Primary outcome
Fistula Recurrence Rate
Time frame: Within 3 months after the final surgical procedure
The proportion of patients in each group with clinically confirmed recurrence of the perianal fistula within 6 months postoperatively. Recurrence is defined as the reappearance of symptoms (pain, discharge) and/or a confirmed tract on postoperative MRI fistulogram.
Postoperative Fecal Incontinence
Time frame: At 3 months postoperatively
Change in anal continence status assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS). The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates worse function. Incontinence is defined as a CCFIS ≥ 5.
3 secondary outcomes
Time to Complete Wound Healing
Time frame: From the date of surgery until the date of documented complete healing, assessed up to 3 months
Postoperative Wound Infection Rate
Time frame: Within 6 weeks postoperatively
Postoperative Pain
Time frame: At 1 week and 2 weeks 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 10 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fistula Rerouting Technique and Ligation of Intersphincteric Fistula Tract in people with High Perianal 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 3 inclusion and 6 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 10 Feb 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 Mostafa Mohamed Sedky, Lecturer (+201066016961, mostafa_mohamed720@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula Recurrence Rate (time frame: Within 3 months after the final surgical procedure). The study lists 2 primary outcomes in all. 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 10 Feb 2026.