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

This study is currently recruiting participants.
Verified November 2011 by Beijing Chao Yang Hospital
Sponsor:
Collaborators:
Peking University Third Hospital
Tianjin Third Central Hospital
Xi’an Jiaotong University College of Medicine
Shaanxi Provincial People's Hospital
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT01478139
First received: November 10, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

November 10, 2011
November 22, 2011
February 2011
August 2012   (final data collection date for primary outcome measure)
The primary outcome measure of this study will be to compare the rate of fistula closure and healing time between the ligation of the intersphincteric fistula track (LIFT) and the LIFT-plug procedure [ Time Frame: 6 month postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01478139 on ClinicalTrials.gov Archive Site
  • recurrence rate [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
    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.
  • fecal incontinence [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
  • complication rates [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anorectal Fistula
  • Extracellular Matrix Alteration
  • Procedure: LIFT-plug
    Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
    Other Name: LIFT-plug
  • Procedure: LIFT
    Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
    Other Name: LIFT
  • Active Comparator: LIFT
    Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
    Intervention: Procedure: LIFT
  • Experimental: LIFT-plug
    Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
    Intervention: Procedure: LIFT-plug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
February 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Zhen Jun Wang, M.D. 86-1085231604 wang3zj@sohu.com
Contact: Li Hua Tian, M.D. 86-1085231217 cyky003@yahoo.com.cn
China
 
NCT01478139
LIFTplug-110212
Yes
Zhen Jun Wang, Beijing Chao Yang Hospital
Zhen Jun Wang
  • Peking University Third Hospital
  • Tianjin Third Central Hospital
  • Xi’an Jiaotong University College of Medicine
  • Shaanxi Provincial People's Hospital
Study Chair: Zhen Jun Wang, M.D. Beijing Chaoyang Hospital, Capital Medical University
Beijing Chao Yang Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP