Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula
2. august 2026 opdateret af: Ain Shams University
Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is a prospective randomized controlled trial comparing ligation of the intersphincteric fistula tract (LIFT) with cyanoacrylate glue (CAG) in the treatment of high transsphincteric perianal fistula.
Adult patients with MRI-confirmed disease will be randomly assigned in a 1:1 ratio to either technique.
The primary outcome is fistula healing , while secondary outcomes include operative time, postoperative pain, complications, recurrence, and continence.
This trial aims to determine the safer and more effective sphincter-preserving approach.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: mohamed Ibrahim khald, Assistant lecturer
- Telefonnummer: +201061399219
- E-mail: mohamed.khald@med.asu.edu.eg
Studiesteder
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Cairo, Egypten
- Rekruttering
- Faculty of medicine ain shams university
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)
Exclusion Criteria:
- Crohn's disease
- Tuberculosis or malignancy-associated fistula
- Horseshoe fistula
- Previous definitive fistula surgery (excluding drainage procedures)
- Pregnancy
- Immunocompromised state (e.g., HIV, chronic steroid use, chemotherapy)
- Uncontrolled diabetes mellitus (HbA1c > 8% )
- Active, undrained perianal sepsis/abscess at the time of scheduled surgery
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Ligation of the intersphincteric fistula tract
Patients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula.
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Patients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula.
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Eksperimentel: Cyanoacrylate Glue (Glubran 2)
cyanoacrylate glue (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote subsequent fistula healing
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Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Complete Fistula Healing Rate
Tidsramme: 3 months post-operative
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Complete epithelialization of the external opening, confirmed clinically and, where indicated, by MRI, with no discharge on gentle compression and no evidence of abscess or infection.
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3 months post-operative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fistula Recurrence Rate
Tidsramme: Up to 12 months post-operative
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Reappearance of discharge, abscess, or fistula tract confirmed clinically and/or by MRI after documented initial healing
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Up to 12 months post-operative
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Change in Fecal Continence
Tidsramme: up to 12 months post-operative
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Change in continence status from baseline using Cleveland Clinic Florida Fecal Incontinence Score (Wexner Score) 0-20 , range 0 [perfect continence] to 20 [complete incontinence]; higher score = worse continence)
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up to 12 months post-operative
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Postoperative Wound Infection Rate
Tidsramme: Within 1 month post-operative
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Clinical signs of infection (erythema, purulent discharge, fever) requiring antibiotic treatment or drainage
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Within 1 month post-operative
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Postoperative Pain Intensity (Visual Analog Scale)
Tidsramme: 24 hours , 1 week and 2 weeks Postoperative
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Self-reported pain intensity will be assessed using the 10-point Visual Analog Scale, where 0 = no pain and 10 = worst pain.
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24 hours , 1 week and 2 weeks Postoperative
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Total Operative Time
Tidsramme: Intraoperative
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Operative time is defined as the time from initial surgical incision or fistula tract access to completion of the procedure, including tract ligation in the LIFT group and complete cyanoacrylate glue instillation in the cyanoacrylate group.
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Intraoperative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. september 2025
Primær færdiggørelse (Anslået)
14. april 2027
Studieafslutning (Anslået)
20. april 2027
Datoer for studieregistrering
Først indsendt
29. juli 2026
Først indsendt, der opfyldte QC-kriterier
2. august 2026
Først opslået (Faktiske)
4. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FMASUGSMD148-9-2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified data for all participants will be shared, including information used to assess the main outcome (fistula healing) and secondary outcomes (operative time, pain after surgery, wound infection, recurrence, and continence score), along with basic demographic and clinical data.
IPD-delingstidsramme
Data will be available beginning 6 months after publication of the primary results and will remain accessible for up to 3 years thereafter.
IPD-delingsadgangskriterier
Access will be granted to qualified researchers who submit a methodologically sound proposal, upon signing a data access/use agreement with the corresponding author.
Requests will be reviewed on a case-by-case basis and require approval from the Institutional Ethics Committee, Ain Shams University, prior to data release.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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