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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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.
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.
Faculty of medicine, Cairo University
Cairo, Al-Manial, Cairo, Egypt, Egypt
RECRUITINGAssessment 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 postoperatively
Operative time
Compare time of operation between both procedure
Time frame: 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.)
Time frame: 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)
Time frame: Up to 6 months postoperatively
Postoperative bleeding
compare Postoperative bleeding in both groups
Time frame: Up to 6 months postoperatively
Postoperative fecal incontinence
Compare post postoperative fecal incontinence in both groups
Time frame: Up to 6 months postoperatively
Time to return to normal activity
Compare Time to return to normal activity in both groups
Time frame: Up to 6 months postoperatively
Postoperative urine retention
compare postoperative urine retention in both groups
Time frame: 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}).
Time frame: At day 1 and day 7 postoperatively
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