Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula

NCT07603635 | Completed

• 1 other identifier: KCTRH-LIFT-944-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Fistula Surgery; Transsphincteric Anal Fistula

Keywords

Anal fistula; Transsphincteric fistula; LIFT; Ligation of intersphincteric fistula tract; Modified LIFT; Sphincter-preserving surgery; Perianal fistula

Outcome Measures

Primary Outcomes (1)

• Wound Healing Time

  Time from surgery to complete clinical epithelialization of the perianal wound without discharge.

  Up to 12 weeks after surgery

Secondary Outcomes (3)

• Early Recurrence or Persistence of Anal Fistula

  Postoperative weeks 1, 4, 8, and 12

• Postoperative Pain Assessed Using the Visual Analog Scale

  Postoperative weeks 1, 4, 8, and 12

• Fecal Continence Assessed Using the Wexner Fecal Incontinence Score

  Postoperative weeks 1, 4, 8, and 12

Study Arms (2)

Modified LIFT via a Lateral Approach

ACTIVE COMPARATOR

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.

Procedure: Modified LIFT via a Lateral Approach

Standard LIFT

ACTIVE COMPARATOR

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.

Procedure: Standard LIFT

Interventions

Standard LIFT PROCEDURE

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.

Standard LIFT

Modified LIFT via a Lateral Approach PROCEDURE

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.

Modified LIFT via a Lateral Approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tugberk Tok: lead

Study Sites (1)

Kayseri City Training and Research Hospital

Kayseri, Kayseri, 38300, Turkey (Türkiye)

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 Officials

• Tuğberk Tok, MD

  Kayseri City Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Yusuf Sevim, MD

  Kayseri City Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: August 30, 2024
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)