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Open Fistulectomy vs. Laser Closure for Low Perianal Fistula

27. august 2026 oppdatert av: Nada Mohamed Abd El Meged, Assiut University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Fistula-tract Laser Closure (FiLaC)
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.
Aktiv komparator: 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.
Fremgangsmåte: Open Fistulectomy
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fistula Healing Rate at 6 Months
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assiut University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

27. august 2026

Først innsendt som oppfylte QC-kriteriene

27. august 2026

Først lagt ut (Faktiske)

1. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FiLaC vs Open Fistulectomy

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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