Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula
21 maj 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Kayseri
-
Kayseri, Kayseri, Turkiet (Türkiye), 38300
- Kayseri City Training and Research Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound Healing Time
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Early Recurrence or Persistence of Anal Fistula
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Tuğberk Tok, MD, Kayseri City Training and Research Hospital
- Studierektor: Yusuf Sevim, MD, Kayseri City Training and Research Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2024
Primärt slutförande (Faktisk)
1 maj 2024
Avslutad studie (Faktisk)
30 augusti 2024
Studieregistreringsdatum
Först inskickad
18 maj 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KCTRH-LIFT-944-2023
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
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