Seton Re-routing for High Perianal Fistula

NCT07850440 | Not Yet Recruiting

• 1 other identifier: Seton Re-routing for Fistula
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

High Perianal Fistula; Fistula-in-Ano; High Anal Fistula

Keywords

Seton re-routing; Loose seton; Sphincter-sparing surgery; High transsphincteric fistula; Anal continence; Wexner incontinence score; Fistulotom

Outcome Measures

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.

  9 months

Study Arms (1)

Two-Stage Seton Re-routing

EXPERIMENTAL

Participants undergo a two-stage seton re-routing procedure: (1) Stage 1: Under spinal or general anesthesia, identification and curettage of the tract followed by loose draining seton placement through the high fistula tract for 6-12 weeks to control sepsis and allow fibrotic maturation. (2) 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 low pathway, isolating the high transsphincteric component to heal by secondary fibrosis. The resulting downstaged low superficial tract is either laid open immediately (low fistulotomy) or managed with staged seton tightening.

Procedure: Seton Re-routing

Interventions

Seton Re-routing PROCEDURE

A 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.

Two-Stage Seton Re-routing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09