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Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula

21. mai 2026 oppdatert av: Tugberk Tok

Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study

This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.

Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.

The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Tyrkia (Türkiye), 38300
        • Kayseri City Training and Research Hospital

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:

  • Age 18 to 75 years
  • Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging
  • Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage
  • Ability and willingness to provide written informed consent
  • Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach

Exclusion Criteria:

  • Previous definitive surgery for perianal fistula other than abscess drainage
  • Perianal Crohn disease
  • Horseshoe fistula
  • Colorectal cancer
  • Malnutrition
  • Recurrent anal fistula
  • Previous radiotherapy or chemotherapy
  • Chronic medication use that could impair wound healing, such as steroids or colchicine
  • Refusal or inability to provide written informed consent

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Modified LIFT via a Lateral Approach
Participants assigned to this arm underwent modified LIFT via a lateral approach. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at this level, and the remaining defect and internal opening were closed while preserving sphincter integrity.
Fremgangsmåte: Modified LIFT via a Lateral Approach
Modified LIFT via a lateral approach was performed. The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed.
Aktiv komparator: Standard LIFT
Participants assigned to this arm underwent standard ligation of the intersphincteric fistula tract (LIFT). The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.
Fremgangsmåte: Standard LIFT
Standard ligation of the intersphincteric fistula tract was performed. The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wound Healing Time
Tidsramme: Up to 12 weeks after surgery
Time from surgery to complete clinical epithelialization of the perianal wound without discharge.
Up to 12 weeks after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Early Recurrence or Persistence of Anal Fistula
Tidsramme: Postoperative weeks 1, 4, 8, and 12
Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up.
Postoperative weeks 1, 4, 8, and 12
Postoperative Pain Assessed Using the Visual Analog Scale
Tidsramme: Postoperative weeks 1, 4, 8, and 12
Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Postoperative weeks 1, 4, 8, and 12
Fecal Continence Assessed Using the Wexner Fecal Incontinence Score
Tidsramme: Postoperative weeks 1, 4, 8, and 12
Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence.
Postoperative weeks 1, 4, 8, and 12

Samarbeidspartnere og etterforskere

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

Sponsor

Tugberk Tok

Etterforskere

  • Hovedetterforsker: Tuğberk Tok, MD, Kayseri City Training and Research Hospital
  • Studieleder: Yusuf Sevim, MD, Kayseri City Training and Research Hospital

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 (Faktiske)

1. januar 2024

Primær fullføring (Faktiske)

1. mai 2024

Studiet fullført (Faktiske)

30. august 2024

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KCTRH-LIFT-944-2023

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions. De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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