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

NCT ID: NCT07102134

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2025-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Anal Fistula Surgery Anal Fistula

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Suturing-LIFT

This group received conventional ligation with absorbable sutures

Group Type ACTIVE_COMPARATOR

Suturing-LIFT procedure

Intervention Type PROCEDURE

This group received conventional ligation with absorbable sutures

Clipped-LIFT

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

Group Type EXPERIMENTAL

Clipped-LIFT procedure

Intervention Type PROCEDURE

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

Interventions

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Suturing-LIFT procedure

This group received conventional ligation with absorbable sutures

Intervention Type PROCEDURE

Clipped-LIFT procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* (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).

Exclusion Criteria

* (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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1010PY(2023)-03

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024ZSLYEC-053

Identifier Type: -

Identifier Source: org_study_id

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