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

31 maj 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

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

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:

  • 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

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: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Fecal Continence Preservation
Tidsram: 12 weeks
12 weeks

Sekundära resultatmått

Resultatmått
Tidsram
Wound Healing Time
Tidsram: 12 weeks
12 weeks
Recurrence Rate
Tidsram: 12 weeks
12 weeks

Samarbetspartners och utredare

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Studieavstämningsdatum

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Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Faktisk)

30 maj 2026

Avslutad studie (Faktisk)

30 maj 2026

Studieregistreringsdatum

Först inskickad

30 april 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

12 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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