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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Anorectal Fistula
Extracellular Matrix Alteration
Procedure: LIFT-plug
Procedure: LIFT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • Healing time [ Time Frame: 1month, 3 month, 6 month postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: February 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: LIFT
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
Other Name: LIFT-plug

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478139

Contacts
Contact: Zhen Jun Wang, M.D. 86-1085231604 wang3zj@sohu.com
Contact: Li Hua Tian, M.D. 86-1085231217 cyky003@yahoo.com.cn

Locations
China, Beijing
Beijing Chaoyang Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100020
Contact: Zhen Jun Wang, M.D.    86-013601393711    wang3zj@sohu.com   
Principal Investigator: Zhen Jun Wang         
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Chao Wen Chen, M.D.    86-013901038133    ccw0070890@sina.com   
Sub-Investigator: Chao Wen Chen, M.D.         
China, Shanxi
Xi'an Jiaotong University College of Medicine Recruiting
Xi'an, Shanxi, China, 710000
Contact: Xiang Ming Che, M.D.    86-018991232115    chexiang@mail.xjtu.edu.cn   
Sub-Investigator: Xiang Ming Che, M.D.         
Shaanxi Provincial People's Hospital Recruiting
Xi'an, Shanxi, China, 710000
Contact: Xiao Qiang Wang, M.D.    86-013991966126    Xiaoqiangwang2008@yahoo.cn   
Sub-Investigator: Xiao Qiang Wang, M.D.         
China, Tianjin
Tianjin Third Central Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Wei Liang Song, M.D.    86-015522242541    songwl2008@sina.com   
Sub-Investigator: Wei Liang Song, M.D.         
Sponsors and Collaborators
Zhen Jun Wang
Peking University Third Hospital
Tianjin Third Central Hospital
Xi’an Jiaotong University College of Medicine
Shaanxi Provincial People's Hospital
Investigators
Study Chair: Zhen Jun Wang, M.D. Beijing Chaoyang Hospital, Capital Medical University
  More Information

No publications provided

Responsible Party: Zhen Jun Wang, Clinical Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT01478139     History of Changes
Other Study ID Numbers: LIFTplug-110212
Study First Received: November 10, 2011
Last Updated: November 26, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Chao Yang Hospital:
anorectal fistula
acellular dermal matrix
ligation of intersphincteric fistula tract
ligation of intersphincteric fistula tract and plug
complications of treatment
recurrence

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 01, 2014