Open Fistulectomy vs. Laser Closure for Low Perianal Fistula
Open Fistulectomy Versus Fistula Tract Laser Closure in Low Perianal Fistula
Perianal fistula is an abnormal tunnel connecting the anal canal to the perianal skin, frequently causing chronic pain, discharge, and impaired quality of life. Traditional open fistulectomy is an established treatment with high healing rates, but it leaves an open wound that requires prolonged recovery and carries a risk of anal sphincter injury. Fistula-tract Laser Closure (FiLaC) is a minimally invasive, sphincter-preserving technique that uses laser thermal energy to close the tract from within while minimizing tissue trauma.
This study is a prospective, randomized controlled trial designed to compare the efficacy and safety of open fistulectomy versus laser fistulotomy in adult patients with primary low perianal fistula.
Participants are randomly assigned to one of two surgical treatment groups:
- Group 1: Laser fistulotomy (FiLaC) using a 1470 nm diode laser probe to seal the tract, combined with internal opening closure.
- Group 2: Conventional open fistulectomy involving complete excision of the fistula tract, allowing the wound to heal by secondary intention.
Patients are evaluated during surgery and followed postoperatively at 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The primary goals are to assess fistula healing rates and postoperative pain levels. Secondary goals include evaluating operative time, intraoperative blood loss, wound healing duration, complication rates, time to return to daily activities, fecal continence (measured by the Wexner Continence Score), and quality of life.
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
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adult patients aged 18 years and above.
- Diagnosis of primary (non-recurrent) low perianal fistula (intersphincteric or low transsphincteric involving less than one-third of the external sphincter) confirmed by clinical examination.
- Fistula tract anatomy confirmed by preoperative endoanal ultrasound (EAUS) and/or pelvic MRI.
- Fit for surgery under spinal or general anesthesia.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Complex or high perianal fistulae (suprasphincteric, extrasphincteric, or involving more than one-third of the external sphincter).
- Recurrent or previously operated perianal fistulae.
- Crohn's disease or other inflammatory bowel disease-associated fistulae.
- Active anorectal sepsis or undrained abscess at the time of enrollment.
- Immunocompromised patients (e.g., HIV/AIDS, long-term systemic corticosteroid therapy, post-organ transplantation).
- Pre-existing fecal incontinence (baseline Wexner Continence Score > 5).
- Pregnant or breastfeeding females.
- Known bleeding disorders or therapeutic anticoagulation that cannot be temporarily safely discontinued.
- History of prior pelvic irradiation.
- Inability or unwillingness to comply with the postoperative follow-up protocol.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Laser Fistulotomy (FiLaC)
Patients undergo Fistula-tract Laser Closure (FiLaC™) using a 1470 nm diode laser system.
The internal opening is curetted and sutured closed with polyglycolic acid suture.
Granulation tissue is debrided with a fistula brush, and a radially emitting laser probe is introduced through the external opening to deliver energy circumferentially (10-14 W) at a continuous withdrawal rate of 1 mm/s to obliterate the tract.
The external opening is left open or loosely sutured for drainage.
|
Debridement of the fistula tract using a fistula brush followed by closure of the internal opening with 2/0 polyglycolic acid suture.
Photothermal obliteration of the tract is achieved using a 1470 nm diode laser system with a 360-degree radial emitting fiber delivering energy circumferentially (10-14 W) during steady withdrawal at 1 mm/s.
|
|
Comparateur actif: Open Fistulectomy
Patients undergo conventional open fistulectomy.
The fistula tract is cannulated with a malleable probe, followed by complete surgical excision of the tract and its epithelialized lining using electrocautery and sharp dissection.
The surgical wound is left open to heal by secondary intention, with wound edge marsupialization performed as needed to prevent premature skin bridging.
|
Complete surgical excision of the fistulous tract from the external opening to the internal opening using sharp dissection and electrocautery over a probe guide.
The resulting wound is left open to heal by secondary intention with wound edge marsupialization performed as necessary.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fistula Healing Rate at 6 Months
Délai: 6 months postoperatively
|
Percentage of participants achieving complete clinical fistula healing, defined as complete epithelialization of the surgical site and external wound with total absence of discharge or purulent drainage on clinical examination, without the need for secondary surgical intervention.
|
6 months postoperatively
|
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
- Les troubles mentaux
- Conditions pathologiques, anatomiques
- Signes et symptômes digestifs
- Maladies intestinales
- Symptômes comportementaux
- Troubles d'élimination
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies rectales
- Fistule du système digestif
- Fistule
- Fistule intestinale
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Fistule rectale
- Encoprésie
Autres numéros d'identification d'étude
- FiLaC vs Open Fistulectomy
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .