Anal Fistula Surgery, High Anal Fistula
Conditions
Keywords
High anal fistula, IFOC, LIFT
Brief 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. 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.
Interventions
PROCEDUREIntra-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.
PROCEDURELigation 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of failure rate of IFOC and LIFT procedures | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Compare time of operation between both procedure |
| surgical site infection | 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.) |
| Time for wound Healing | 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) |
| Postoperative bleeding | Up to 6 months postoperatively | compare Postoperative bleeding in both groups |
| Postoperative fecal incontinence | Up to 6 months postoperatively | Compare post postoperative fecal incontinence in both groups |
| Time to return to normal activity | Up to 6 months postoperatively | Compare Time to return to normal activity in both groups |
| Postoperative urine retention | Within 48 hours postoperatively | compare postoperative urine retention in both groups |
| Pain intensity | 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}). |
Countries
Egypt
Contacts
CONTACTAhmed Mohamed Abdelaal, MD
STUDY_DIRECTORMohamed Yehia Elbarmalgi, MD
Cairo University
Outcome results
None listed