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Anal FistulaLIFT-SETONNCT07579715

Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula

A study testing Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement in people with Anal Fistula and Perianal Fistula, run by Islamabad Medical and Dental College at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anal Fistula, Perianal Fistula, Fistula-in-ano
What is being tested?
Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
1 Jan 2026to 30 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Ligation of Intersphincteric Fistula Tract (LIFT), Fistulotomy with Seton Placement
Medical subject headings
Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ligation of Intersphincteric Fistula Tract (LIFT)Procedure or surgery

    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.

  • Fistulotomy with Seton PlacementProcedure or surgery

    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.

Study groups in NCT07579715
Study groupRoleWhat they receive
Lift GroupActive comparatorParticipants 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.
Receives: Procedure: Ligation of Intersphincteric Fistula Tract (LIFT)
Fistulotomy With Seton GroupActive comparatorParticipants 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.
Receives: Procedure: Fistulotomy with Seton Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal Continence Preservation

    Measured: 12 weeks

Secondary outcomes (2)
  1. Wound Healing Time

    Measured: 12 weeks

  2. Recurrence Rate

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 Jan 2026
  3. Primary completion30 May 2026
  4. Study completion30 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants will be assigned into two parallel groups based on the surgical procedure received. Group A will undergo Ligation of the Intersphincteric Fistula Tract (LIFT) procedure, while Group B will undergo fistulotomy with seton placement followed by definitive fistulotomy. Outcomes will be compared between the two groups.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07579715
Sponsor's protocol ID
CRS-2024-135-7
Acronym
LIFT-SETON
Status last verified
May 2026
First submitted
30 Apr 2026
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ligation of Intersphincteric Fistula Tract (LIFT) and Fistulotomy with Seton Placement in people with Anal Fistula and Perianal Fistula, run by Islamabad Medical and Dental College at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fecal Continence Preservation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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