Comparative Study: Fistula Rerouting vs. LIFT for High Perianal Fistula
ConditionHigh Perianal Fistula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorCairo University
About this trial
The goal of this clinical trial is to compare two different surgery methods for treating a complex type of anal fistula. This condition is an abnormal tunnel connecting the inside of the anus to the skin nearby. The main questions the study aims to answer are:
Which surgery has a lower chance of the fistula coming back (recurrence)?
Which surgery has a lower chance of causing problems with bowel control (incontinence) after healing?
Researchers will compare two surgery groups:
Group 1: Fistula Rerouting Technique - a two-step surgery that moves the fistula tract to a safer area before opening it.
Group 2: LIFT Technique - a surgery that ties off and closes the fistula tract from between the anal muscles.
Participants will be randomly assigned by a computer to one of these two surgery groups. This helps ensure the comparison between the two surgeries is fair.
Participants in this study will:
* Have tests before surgery, including an MRI scan, to confirm they have the specific type of fistula being studied. * Undergo one of the two planned surgical procedures. * Attend follow-up visits after surgery at 1 week, 2 weeks, 1 month, and 3 months. * Be checked during these visits for wound healing, pain, infection, and bowel control. * Have another MRI scan if the fistula is suspected to have come back.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age 20-65 years) presenting with a high perianal fistula, defined as:Trans-sphincteric fistula tract traversing the upper two-thirds of the external anal sphincter, Or Extrasphincteric fistula.
Patients with recurrent perianal fistula.
Ability to provide informed consent.
Disqualifiers
Patients with preoperative fecal incontinence (as assessed by the Cleveland Clinic Fecal Incontinence Score).
Diagnosis of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
Pregnant women.
Pediatric patients (age < 20 years).
Trial design
Design model
Parallel
Treatments tested in this trial
Fistula Rerouting Technique
Procedure/SurgeryA two-stage, sphincter-preserving surgical procedure for high perianal fistula. Stage 1: The native fistulous tract is surgically dissected and transposed from its trans-sphincteric course into the intersphincteric plane. The defect in the external sphincter is repaired. Stage 2: After complete healing of the first-stage wound, a fistulotomy is performed on the newly created intersphincteric tract. The goal is to eradicate the fistula while minimizing injury to the anal sphincter complex.
Ligation of Intersphincteric Fistula Tract
Procedure/SurgeryA single-stage, sphincter-preserving surgical procedure for perianal fistula. The fistula tract is accessed via an incision in the intersphincteric groove. The tract is identified, dissected, divided, and both ends are ligated. The infected cryptoglandular tissue is excised. The internal and external wounds are debrided and left open to heal by secondary intention. The goal is to close the fistula tract at its origin while preserving sphincter function.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Fistula Rerouting Technique GroupExperimental treatment 1 intervention
Group B: LIFT Technique GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fistula Recurrence Rate
The proportion of patients in each group with clinically confirmed recurrence of the perianal fistula within 6 months postoperatively. Recurrence is defined as the reappearance of symptoms (pain, discharge) and/or a confirmed tract on postoperative MRI fistulogram.
Time frame
Within 3 months after the final surgical procedure2
Postoperative Fecal Incontinence
Change in anal continence status assessed using the Cleveland Clinic Fecal Incontinence Score (CCFIS). The score ranges from 0 (perfect continence) to 20 (complete incontinence). A higher score indicates worse function. Incontinence is defined as a CCFIS ≥ 5.
Time frame
At 3 months postoperativelySecondary outcomes
1
Time to Complete Wound Healing
The number of days required for the surgical wound to heal completely, defined as full epithelialization with no discharge
Time frame
From the date of surgery until the date of documented complete healing, assessed up to 3 months2
Postoperative Wound Infection Rate
The proportion of patients in each group developing surgical site infection, defined by the presence of purulent discharge, erythema, warmth, or tenderness requiring antibiotic treatment or intervention.
Time frame
Within 6 weeks postoperatively3
Postoperative Pain
Patient-reported pain intensity assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame
At 1 week and 2 weeks postoperativelySponsors and contacts
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Source ClinicalTrials.gov