IFOC Compared With LIFT in High Anal Fistula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with high anal fistula from both gender
Disqualifiers
Patient with preoperative fecal incontinence
Fistula secondary to colorectal malignancy
Patients with inflammatory bowel disease
Fistula secondary to trauma or radiation
Trial design
Design model
Parallel
Treatments tested in this trial
Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)
Procedure/SurgeryThe 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/SurgeryThe 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Intra-anal Fistulotomy With Fistula Opening Closure (IFOC)Experimental treatment 1 intervention
Group B: Ligation of the Intersphincteric Fistula Tract (LIFT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.)
Time frame
Up to 6 months postoperativelySecondary outcomes
1
Operative time
Compare time of operation between both procedure
Time frame
During surgery2
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.)
Time frame
Up to 6 months postoperatively3
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)
Time frame
Up to 6 months postoperatively4
Postoperative bleeding
compare Postoperative bleeding in both groups
Time frame
Up to 6 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov