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NCT Number: NCT07520500

IFOC Compared With LIFT in High Anal Fistula

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.

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Key information

Conditions

Anal Fistula Surgery High Anal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, 11451, Egypt

Location status: Recruiting

Location contact

Ahmed Mohamed Abdelaal, MD

CONTACT

[email protected]

+201118732767

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with high anal fistula from both gender

Exclusion criteria

  • Patient with preoperative fecal incontinence
  • Fistula secondary to colorectal malignancy
  • Patients with inflammatory bowel disease
  • Fistula secondary to trauma or radiation
  • Low anal fistula

Treatment and study plan

Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)

Procedure

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

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.

Primary outcomes

  1. 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.)

Secondary outcomes

  1. Operative time

    Time frame: During surgery

    Compare time of operation between both procedure

  2. surgical site infection

    Time frame: Up to 6 months postoperatively

    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.)

  3. Time for wound Healing

    Time frame: Up to 6 months postoperatively

    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)

  4. Postoperative bleeding

    Time frame: Up to 6 months postoperatively

    compare Postoperative bleeding in both groups

  5. Postoperative fecal incontinence

    Time frame: Up to 6 months postoperatively

    Compare post postoperative fecal incontinence in both groups

  6. Time to return to normal activity

    Time frame: Up to 6 months postoperatively

    Compare Time to return to normal activity in both groups

  7. Postoperative urine retention

    Time frame: Within 48 hours postoperatively

    compare postoperative urine retention in both groups

  8. Pain intensity

    Time frame: At day 1 and day 7 postoperatively

    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}).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdelaal, MD

CONTACT

[email protected]

+201118732767

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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