Seton Re-routing for High Perianal Fistula
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
High perianal fistulae involve a significant portion of the external anal sphincter muscle, making standard surgical fistulotomy risky due to the potential for postoperative fecal incontinence. Sphincter-preserving techniques aim to eradicate the fistula tract and promote healing while safeguarding anal continence.
The purpose of this prospective, single-arm clinical study is to evaluate the efficacy and safety of the two-stage seton re-routing technique in adult patients diagnosed with high perianal fistula at Assiut University Hospital.
The procedure is conducted in two stages:
* First Stage: Identification and curettage of the fistula tract followed by placement of a loose draining seton to clear local sepsis and allow fibrous maturation over an interval of 6 to 12 weeks. * Second Stage: Creation of a low submucosal or intersphincteric tunnel beneath the main external anal sphincter complex. The seton is unthreaded and re-routed through this lower pathway, isolating the upper transsphincteric tract so it can heal spontaneously by secondary fibrosis. The resulting downstaged superficial tract is then laid open (low fistulotomy) or managed with staged seton tightening.
Participants will be monitored weekly during the first month, followed by regular monthly follow-up visits for a minimum of 6 to 9 months postoperatively. The study assesses complete fistula healing, recurrence rates, healing time, operative duration, postoperative complications, and anal continence status evaluated using the Cleveland Clinic (Wexner) Incontinence Score preoperatively and at 3, 6, and 9 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older, of either sex.
Diagnosed with high perianal fistula (fistula tract involving the upper two-thirds of the external anal sphincter).
De novo or recurrent perianal fistula.
American Society of Anesthesiologists (ASA) physical status classification I or II.
Disqualifiers
Fistula secondary to inflammatory bowel disease (Crohn's disease or ulcerative colitis), malignancy, tuberculosis, trauma, or prior pelvic irradiation.
Pre-existing fecal incontinence.
Uncontrolled diabetes mellitus or immunosuppressive conditions impairing wound healing.
Trial design
Design model
Single group
Treatments tested in this trial
Seton Re-routing
Procedure/SurgeryA two-stage sphincter-sparing surgical procedure: Stage 1: Under spinal or general anesthesia, identification and curettage of the tract, followed by placement of a loose draining seton through the high fistula tract for 6 to 12 weeks to control local sepsis and promote fibrotic maturation. Stage 2: An incision is made in the intersphincteric plane beneath the main external anal sphincter body to create a low submucosal or intersphincteric tunnel toward the dentate line. The seton is untied and re-routed through this lower pathway, isolating the high transsphincteric component to heal spontaneously by secondary fibrosis. The resulting downstaged low tract is either laid open immediately (low fistulotomy) or managed by staged seton tightening.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Two-Stage Seton Re-routingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Complete Fistula Healing
Complete fistula healing is defined as complete epithelialization and closure of both external and internal openings, with absence of discharge, pain, and induration on clinical examination.
Time frame
9 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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