The Modified Clipped-LIFT Procedure for High Transsphincteric or Suprasphincteric Fistula

NCT07102134 | Completed

• 2 other identifiers: 2024ZSLYEC-0531010PY(2023)-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective analysis was performed on 96 patients who underwent modified LIFT procedures to treat transsphincteric or suprasphincteric fistulas. Two distinct methods were utilized to ligate the internal sphincter side of the intersphincteric tract: one group received conventional ligation with absorbable sutures (Suturing-LIFT, n=74), while the other group was treated with absorbable clips commonly used for vascular or biliary duct occlusion (Clipped-LIFT, n=22). The primary outcome was the one-stage healing rate, which was compared between the two groups, and the safety profile of the clipped-LIFT approach was analyzed. Both univariate and multivariate analyses were conducted to identify potential prognostic factors associated with therapeutic outcomes.

Conditions

Anal Fistula Surgery; Anal Fistula

Keywords

High anal fistula; Ligation of the Intersphincteric Fistula Tract procedure; Sphincter-preserving; Clipped ligation.

Outcome Measures

Primary Outcomes (1)

• the one-stage healing rate

  Complete wound healing without discharge more than 6 months after the modified LIFT procedure

Study Arms (2)

Suturing-LIFT

ACTIVE COMPARATOR

This group received conventional ligation with absorbable sutures

Procedure: Suturing-LIFT procedure

Clipped-LIFT

EXPERIMENTAL

This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion

Procedure: Clipped-LIFT procedure

Interventions

Suturing-LIFT procedure PROCEDURE

This group received conventional ligation with absorbable sutures

Suturing-LIFT

Clipped-LIFT procedure PROCEDURE

This group was treated with absorbable clips commonly used for vascular or biliary duct occlusion

Clipped-LIFT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) preoperative pelvic MRI confirming Parks classification; (2) all patients undergoing a modified LIFT procedure, either with suture ligation (suturing-LIFT group) or clip ligation (clipped-LIFT group).

You may not qualify if:

• (1) presence of secondary rectal or anal openings identified as unsuitable for LIFT during postoperative evaluation; (2) lack of clinical outcomes following initial modified LIFT procedure.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: March 1, 2020
• Primary Completion: March 13, 2020
• Study Completion: May 15, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (1)