Seton Re-routing for High Perianal Fistula
Seton Re-routing for Treatment of High Perianal Fistula
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Two-Stage Seton Re-routing
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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Complete Fistula Healing
Délai: 9 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Seton Re-routing for Fistula
Informations sur les médicaments et les dispositifs, documents d'étude
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