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

NCT07579715 | Completed

• 1 other identifier: CRS-2024-135-7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anal Fistula; Perianal Fistula; Fistula-in-ano

Outcome Measures

Primary Outcomes (1)

• Fecal Continence Preservation

  12 weeks

Secondary Outcomes (2)

• Wound Healing Time

  12 weeks

• Recurrence Rate

  12 weeks

Study Arms (2)

Lift Group

ACTIVE COMPARATOR

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.

Procedure: Ligation of Intersphincteric Fistula Tract (LIFT)

Fistulotomy With Seton Group

ACTIVE COMPARATOR

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.

Procedure: Fistulotomy with Seton Placement

Interventions

Fistulotomy with Seton Placement PROCEDURE

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.

Fistulotomy With Seton Group

Ligation of Intersphincteric Fistula Tract (LIFT) PROCEDURE

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.

Lift Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied in this study due to the nature of surgical interventions. Participants, surgeons, and outcome assessors will be aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 12, 2026
• Study Start: January 1, 2026
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)