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Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula (LIFT-SETON)

13 maggio 2026 aggiornato da: Islamabad Medical and Dental College

Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In The Management Of Perianal Fistula: An Analytical Comparative Study

This study aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Perianal fistula is a condition that can cause pain, discharge, and significant discomfort, and its treatment remains challenging due to the risk of recurrence and potential loss of bowel control after surgery.

The LIFT procedure is a sphincter-preserving technique designed to treat the fistula without damaging the muscles responsible for continence. In contrast, fistulotomy with seton involves placing a thread (seton) in the fistula tract followed by gradual or staged division of the tract, which may carry a higher risk of affecting continence.

In this study, 100 adult patients diagnosed with perianal fistula will be included and divided into two groups based on the surgical procedure they undergo: LIFT or fistulotomy with seton. The outcomes of both procedures will be compared in terms of wound healing time, recurrence of the fistula, postoperative pain, and preservation of bowel continence.

The results of this study will help determine which surgical technique provides better recovery, fewer complications, and improved quality of life for patients.

Panoramica dello studio

Descrizione dettagliata

Perianal fistula (fistula-in-ano) is a common anorectal condition characterized by an abnormal tract between the anal canal and perianal skin. It is associated with recurrent infection, discharge, and discomfort, and often requires surgical management. However, the ideal surgical technique remains controversial due to the balance required between complete eradication of the fistula tract and preservation of anal sphincter function.

Traditional surgical approaches such as fistulotomy involve laying open the fistula tract but may result in varying degrees of sphincter muscle division, leading to potential fecal incontinence. To overcome this limitation, sphincter-preserving techniques such as the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure have been introduced. LIFT involves identification and ligation of the fistula tract in the intersphincteric plane, thereby minimizing damage to the anal sphincter.

Fistulotomy with seton placement is another commonly practiced technique, especially for trans-sphincteric fistulas. The seton allows gradual drainage and fibrosis before definitive fistulotomy, potentially reducing the risk of uncontrolled sphincter division but still carrying a risk of incontinence.

Despite numerous international studies comparing these techniques, results remain inconsistent due to variations in study design, patient populations, and surgical expertise. Moreover, limited local data from Pakistan necessitates further research to guide clinical decision-making in this setting.

This analytical comparative study will be conducted at the Colorectal and General Surgery Department of Akbar Niazi Teaching Hospital, Islamabad. A total of 100 patients aged 18-65 years with primary trans-sphincteric or inter-sphincteric perianal fistula will be included using non-probability consecutive sampling. Patients will be allocated into two groups based on the surgical procedure performed: Group A (LIFT) and Group B (fistulotomy with seton).

Preoperative data including demographic characteristics, fistula type, and baseline continence scores will be recorded. Surgical procedures will be standardized and performed or supervised by experienced surgeons. Postoperative follow-up will be conducted at 2, 4, 8, and 12 weeks to assess outcomes.

The primary outcome of the study is preservation of fecal continence at 12 weeks, assessed using a validated continence scoring system. Secondary outcomes include wound healing time, recurrence rate, postoperative pain scores, and overall complication rate.

Data will be analyzed using statistical software. Continuous variables will be compared using independent-sample t-tests, while categorical variables will be analyzed using chi-square tests. A p-value of less than 0.05 will be considered statistically significant. Multivariate analysis may be performed to adjust for confounding factors.

This study aims to provide evidence on the comparative effectiveness and safety of LIFT versus fistulotomy with seton, helping surgeons select the most appropriate technique with optimal patient outcomes and minimal complications.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Islamabad, Pakistan, 44000
        • Reclutamento
        • Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients aged 18-65 years, both males and females
  • Diagnosed with primary cryptoglandular perianal fistula
  • Trans-sphincteric or inter-sphincteric fistula confirmed clinically ± imaging/proctoscopy
  • Fit for surgery under anesthesia
  • Willing to provide written informed consent

Exclusion Criteria:

  • Recurrent perianal fistula (previous surgical intervention)
  • Fistula secondary to Crohn's disease, tuberculosis, or malignancy Immunocompromised patients
  • Pre-existing fecal incontinence (documented)
  • Severe comorbidities making surgery unsafe (e.g., uncontrolled diabetes, severe hepatic/renal failure)
  • Pregnancy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Lift Group
Participants in this arm will undergo the Ligation of the Intersphincteric Fistula Tract (LIFT) procedure for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. This is a sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter integrity. Postoperative outcomes, including wound healing time, recurrence, postoperative pain, and faecal continence, will be assessed and compared with the fistulotomy with seton group during follow-up.
A sphincter-preserving surgical technique in which the fistula tract is identified in the intersphincteric plane, ligated, and divided to close the internal opening while preserving anal sphincter function.
Comparatore attivo: Fistulotomy With Seton Group
Participants in this arm will undergo fistulotomy with seton placement followed by definitive fistulotomy for the management of primary trans-sphincteric or inter-sphincteric perianal fistula. The seton is used initially to allow drainage and fibrosis of the fistula tract, followed by surgical laying open of the tract (fistulotomy) as definitive treatment. Postoperative outcomes, including wound healing time, recurrence rate, postoperative pain, and faecal continence, will be evaluated and compared with the LIFT group during scheduled follow-up visits.
A surgical approach involving placement of a seton through the fistula tract followed by fistulotomy (laying open of the tract) as definitive management for perianal fistula.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Fecal Continence Preservation
Lasso di tempo: 12 weeks
12 weeks

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Wound Healing Time
Lasso di tempo: 12 weeks
12 weeks
Recurrence Rate
Lasso di tempo: 12 weeks
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

30 giugno 2026

Completamento dello studio (Stimato)

30 giugno 2026

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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