Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula

Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Transsphincteric Anal Fistula; Anal Fistula Surgery
• Intervention / Treatment: Procedure: Modified LIFT via a Lateral Approach; Procedure: Standard LIFT

Detailed Description

This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.

Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.

The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri
    • Kayseri, Kayseri, Turkey (Türkiye), 38300
      • Kayseri City Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Modified LIFT via a Lateral Approach; 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; 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.
Active Comparator: Standard LIFT; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Time	Time from surgery to complete clinical epithelialization of the perianal wound without discharge.	Up to 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Recurrence or Persistence of Anal Fistula	Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up.	Postoperative weeks 1, 4, 8, and 12
Postoperative Pain Assessed Using the Visual Analog Scale	Postoperative pain will be assessed using the Visual Analog Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.	Postoperative weeks 1, 4, 8, and 12
Fecal Continence Assessed Using the Wexner Fecal Incontinence Score	Fecal continence will be assessed using the Wexner Fecal Incontinence Score. The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate worse continence.	Postoperative weeks 1, 4, 8, and 12

Collaborators and Investigators

• Sponsor: Tugberk Tok
• Investigators: Principal Investigator: Tuğberk Tok, MD, Kayseri City Training and Research Hospital; Study Director: Yusuf Sevim, MD, Kayseri City Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anal fistula; LIFT; Perianal fistula; Transsphincteric fistula; Ligation of intersphincteric fistula tract; Modified LIFT; Sphincter-preserving surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Rectal Fistula
• Other Study ID Numbers: KCTRH-LIFT-944-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions. De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No