Anal Fistula SurgeryNCT07520500
IFOC Compared With LIFT in High Anal Fistula
A study testing Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) and Ligation of the Intersphincteric Fistula Tract (LIFT) in people with Anal Fistula Surgery and High Anal Fistula, run by Cairo University at 1 site in Egypt.
Trial summary
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. The study purpose will be explained, and informed consent will be obtained from eligible participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula Surgery, High Anal Fistula
- What is being tested?
- Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) and Ligation of the Intersphincteric Fistula Tract (LIFT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2026to 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high anal fistula from both gender
Who cannot join
- Patient with preoperative fecal incontinence
- Fistula secondary to colorectal malignancy
- Patients with inflammatory bowel disease
- Fistula secondary to trauma or radiation
- Low anal fistula
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, Egypt, 11451
Ahmed Mohamed Abdelaal, MD, +201118732767, drabdelaal90@gmail.com
About this study
Official title: Early Outcomes of Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) Compared With Ligation of the Intersphincteric Fistula Tract (LIFT) in High Anal Fistula: A Pilot Randomized Controlled Trial
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. The study purpose will be explained, and informed consent will be obtained from eligible participants. A detailed medical history and routine preoperative assessment will be conducted.
Clinical evaluation will include identification of the internal and external openings, assessment of discharge, and continence status using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to evaluate the fistula tract and its relation to the sphincter complex.
Read more
Patients will be randomly allocated into two equal groups (1:1 ratio) using a computer-generated sequence:
Group A: Undergo LIFT procedure Group B: Undergo IFOC procedure Both procedures will be performed as per standard surgical techniques. Postoperatively, patients will start oral fluids after 2 hours and resume a normal diet as tolerated. Discharge is planned on the first postoperative day unless otherwise indicated. Follow-up will be conducted at 1 week, 2 weeks, 1 month, and monthly thereafter for at least 6 months to assess healing and detect complications, including recurrence.
Read the detailed description
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. High anal fistula is defined as involvement of more than one-third of the sphincter complex. Patients with inflammatory bowel disease, low anal fistula, fistula secondary to colorectal malignancy, pre-existing fecal incontinence, or previous levator ani muscle injury will be excluded. The study will be explained to eligible patients, and informed consent will be obtained.
All patients will undergo detailed history taking and clinical examination, including identification of internal and external openings, assessment of discharge, and evaluation of continence using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to define the fistulous tract and its relation to the sphincter complex.
Patients will be randomly allocated into two equal groups using a computer-generated sequence. Group A will undergo the LIFT procedure, while Group B will undergo the IFOC procedure.
In the LIFT procedure, the fistulous tract will be identified, dissected in the intersphincteric plane, ligated at two points, and divided. The external opening will be curetted and left for drainage. In the IFOC procedure, the tract will be identified and opened intra-anally, followed by curettage and closure of the internal opening with absorbable sutures, with drainage of the external tract.
Postoperatively, patients will resume oral intake within hours after surgery and are usually discharged on the first postoperative day. Follow-up will be conducted at regular intervals for at least six months to assess healing, continence, complications, and recurrence.
- Conditions
- Anal Fistula Surgery, High Anal Fistula
- Being tested
- Intra-anal Fistulotomy With Fistula Opening Closure (IFOC), Ligation of the Intersphincteric Fistula Tract (LIFT)
- Keywords
- High anal fistula, IFOC, LIFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)Procedure or surgery
The fistulous tract was identified using an arterial clamp and confirmed by water injection. Intra-anal fistulotomy was performed with electrocautery, followed by curettage of granulation tissue. The internal opening was closed with absorbable sutures in a horizontal mattress fashion, with closure confirmed by water injection. The external tract was further curetted, a tube drain was inserted, and reinforcing sutures were applied to promote healing.
Ligation of the Intersphincteric Fistula Tract (LIFT)Procedure or surgery
The internal opening was identified by injection through the external opening. The tract was dissected in the intersphincteric plane, ligated at two points, and divided. Closure was confirmed by reinjection, the external opening was curetted and drained, and the incision was loosely closed.
| Study group | Role | What they receive |
|---|---|---|
| Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) | Experimental | Patient with high anal fistula will be treated with Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) Receives: Procedure: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) |
| Ligation of the Intersphincteric Fistula Tract (LIFT) | Active comparator | patient with high anal fistula will be treated with Ligation of the Intersphincteric Fistula Tract (LIFT) Receives: Procedure: Ligation of the Intersphincteric Fistula Tract (LIFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of failure rate of IFOC and LIFT procedures
Assessment of failure rate, defined as failure of healing or recurrence of anal fistula during the follow-up period, in both treatment groups. (Healing is defined as: Complete closure of the external opening, Absence of pus discharge , Absence of local pain or inflammation and No detectable tract on examination ) (Recurrence is defined as: Reappearance of discharge from the previous external opening after initial healing, or development of a new fistulous opening at or near the surgical site.)
Measured: Up to 6 months postoperatively
Secondary outcomes (8)
Operative time
Compare time of operation between both procedure
Measured: During surgery
surgical site infection
compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)
Measured: Up to 6 months postoperatively
Time for wound Healing
Time for wound Healing in both groups (Healing is defined as: Complete closure of the external opening, Absence of pus discharge , Absence of local pain or inflammation and No detectable tract on examination)
Measured: Up to 6 months postoperatively
Postoperative bleeding
compare Postoperative bleeding in both groups
Measured: Up to 6 months postoperatively
Postoperative fecal incontinence
Compare post postoperative fecal incontinence in both groups
Measured: Up to 6 months postoperatively
Time to return to normal activity
Compare Time to return to normal activity in both groups
Measured: Up to 6 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 posted9 Apr 2026
- Study start19 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fistula SurgeryStudies 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
- 66 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
- Mohamed Yehia Elbarmalgi, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520500
- Sponsor's protocol ID
- N-58-2026
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 22 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) Compared With Ligation of the Intersphincteric Fistula Tract (LIFT) in High Anal Fistula: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520500
- Acronym / sponsor ID
- N-58-2026
- Conditions
- Anal Fistula Surgery, High Anal Fistula
- Keywords
- High anal fistula, IFOC, LIFT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 9 Apr 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.
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. The study purpose will be explained, and informed consent will be obtained from eligible participants. A detailed medical history and routine preoperative assessment will be conducted.
Clinical evaluation will include identification of the internal and external openings, assessment of discharge, and continence status using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to evaluate the fistula tract and its relation to the sphincter complex.
Patients will be randomly allocated into two equal groups (1:1 ratio) using a computer-generated sequence:
Group A: Undergo LIFT procedure Group B: Undergo IFOC procedure Both procedures will be performed as per standard surgical techniques. Postoperatively, patients will start oral fluids after 2 hours and resume a normal diet as tolerated. Discharge is planned on the first postoperative day unless otherwise indicated. Follow-up will be conducted at 1 week, 2 weeks, 1 month, and monthly thereafter for at least 6 months to assess healing and detect complications, including recurrence.
Detailed description
Patients presenting to the outpatient clinic at Kasr Al-Ainy Hospitals with high anal fistula will be assessed according to the inclusion and exclusion criteria. High anal fistula is defined as involvement of more than one-third of the sphincter complex. Patients with inflammatory bowel disease, low anal fistula, fistula secondary to colorectal malignancy, pre-existing fecal incontinence, or previous levator ani muscle injury will be excluded. The study will be explained to eligible patients, and informed consent will be obtained.
All patients will undergo detailed history taking and clinical examination, including identification of internal and external openings, assessment of discharge, and evaluation of continence using the Jorge-Wexner incontinence score. MRI fistulogram will be performed preoperatively to define the fistulous tract and its relation to the sphincter complex.
Patients will be randomly allocated into two equal groups using a computer-generated sequence. Group A will undergo the LIFT procedure, while Group B will undergo the IFOC procedure.
In the LIFT procedure, the fistulous tract will be identified, dissected in the intersphincteric plane, ligated at two points, and divided. The external opening will be curetted and left for drainage. In the IFOC procedure, the tract will be identified and opened intra-anally, followed by curettage and closure of the internal opening with absorbable sutures, with drainage of the external tract.
Postoperatively, patients will resume oral intake within hours after surgery and are usually discharged on the first postoperative day. Follow-up will be conducted at regular intervals for at least six months to assess healing, continence, complications, and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) | Experimental | Procedure: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)Patient with high anal fistula will be treated with Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) |
| Ligation of the Intersphincteric Fistula Tract (LIFT) | Active comparator | Procedure: Ligation of the Intersphincteric Fistula Tract (LIFT)patient with high anal fistula will be treated with Ligation of the Intersphincteric Fistula Tract (LIFT) |
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 from both gender
Key exclusion criteria (5 listed)
- Patient with preoperative fecal incontinence
- Fistula secondary to colorectal malignancy
- Patients with inflammatory bowel disease
- Fistula secondary to trauma or radiation
- Low anal fistula
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 |
|---|---|---|
| Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)The fistulous tract was identified using an arterial clamp and confirmed by water injection. Intra-anal fistulotomy was performed with electrocautery, followed by curettage of granulation tissue. The internal opening was closed with absorbable sutures in a horizontal mattress fashion, with closure confirmed by water injection. The external tract was further curetted, a tube drain was inserted, and reinforcing sutures were applied to promote healing. | Procedure or surgery | Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) |
| Ligation of the Intersphincteric Fistula Tract (LIFT)The internal opening was identified by injection through the external opening. The tract was dissected in the intersphincteric plane, ligated at two points, and divided. Closure was confirmed by reinjection, the external opening was curetted and drained, and the incision was loosely closed. | Procedure or surgery | Ligation of the Intersphincteric Fistula Tract (LIFT) |
Primary outcome
Assessment of failure rate of IFOC and LIFT procedures
Time frame: Up to 6 months postoperatively
Assessment of failure rate, defined as failure of healing or recurrence of anal fistula during the follow-up period, in both treatment groups. (Healing is defined as: Complete closure of the external opening, Absence of pus discharge , Absence of local pain or inflammation and No detectable tract on examination ) (Recurrence is defined as: Reappearance of discharge from the previous external opening after initial healing, or development of a new fistulous opening at or near the surgical site.)
8 secondary outcomes
Operative time
Time frame: During surgery
surgical site infection
Time frame: Up to 6 months postoperatively
Time for wound Healing
Time frame: Up to 6 months postoperatively
Postoperative bleeding
Time frame: Up to 6 months postoperatively
Postoperative fecal incontinence
Time frame: Up to 6 months postoperatively
Time to return to normal activity
Time frame: Up to 6 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 22 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.
Mohamed Yehia Elbarmalgi, MD 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 Intra-anal Fistulotomy With Fistula Opening Closure (IFOC) and Ligation of the Intersphincteric Fistula Tract (LIFT) in people with Anal Fistula Surgery and 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 5 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 22 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, MD (+201118732767, drabdelaal90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of failure rate of IFOC and LIFT procedures (time frame: Up to 6 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 22 May 2026.