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OpenTrials
Completed

NCT Number: NCT07102134

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suturing-LIFT procedure

Procedure

This group received conventional ligation with absorbable sutures

Clipped-LIFT procedure

Procedure

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

Primary outcomes

  1. the one-stage healing rate

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

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

The Modified Clipped Ligation of Intersphincteric Fistula Tract (Clipped-LIFT) for High Transsphincteric or Suprasphincteric Fistula: a Proof-of-concept Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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