Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair (LIFT-plug)

November 26, 2013 updated by: Zhen Jun Wang

Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial

The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment.

The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively.

The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Sub-Investigator:
          • Chao Wen Chen, M.D.
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
        • Sub-Investigator:
          • Xiao Qiang Wang, M.D.
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • Xi'an Jiaotong University College of Medicine
        • Contact:
        • Sub-Investigator:
          • Xiang Ming Che, M.D.
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Third Central Hospital
        • Contact:
        • Sub-Investigator:
          • Wei Liang Song, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects over eighteen years old or less than 65 years old.
  • Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
  • Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).

Exclusion Criteria:

  • Presence of horseshoe fistula.
  • History of immunosuppression therapy/treatment within previous six months.
  • Fistulas with active abscess, infection, or acute inflammation
  • History of Choron's Disease
  • History of Ulcerative Colitis
  • History of HIV or other immune system disease
  • History of collagen disease
  • History of radiation to the anorectal region
  • Allergies to pig tissue or pig products
  • Religious or cultural objection to the use of pig tissue

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
Procedure: LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
Experimental: LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
Procedure: LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing time
Time Frame: 1month, 3 month, 6 month postoperatively
1month, 3 month, 6 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: 1month, 3 month, 6 month postoperatively
1month, 3 month, 6 month postoperatively
postoperative pain
Time Frame: 1month, 3 month, 6 month postoperatively
The methodology used for the evaluation of postoperative perineal pain severity and relief, is the visual analogue scale (VAS) (1-10). We considered positive a VAS > 4.
1month, 3 month, 6 month postoperatively
fecal incontinence
Time Frame: 1month, 3 month, 6 month postoperatively
1month, 3 month, 6 month postoperatively
complication rates
Time Frame: 1month, 3 month, 6 month postoperatively
1month, 3 month, 6 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhen Jun Wang

Collaborators

Peking University Third Hospital
Shaanxi Provincial People's Hospital
Tianjin Third Central Hospital
Health Science Center of Xi'an Jiaotong University

Investigators

  • Study Chair: Zhen Jun Wang, M.D., Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIFTplug-110212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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