NCT01478139

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2011

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

November 10, 2011

Last Update Submit

November 26, 2013

Conditions

Anorectal FistulaExtracellular Matrix Alteration

Keywords

anorectal fistulaacellular dermal matrixligation of intersphincteric fistula tractligation of intersphincteric fistula tract and plugcomplications of treatmentrecurrence

Outcome Measures

Primary Outcomes (1)

  • Healing time

    1month, 3 month, 6 month postoperatively

Secondary Outcomes (4)

  • recurrence rate

    1month, 3 month, 6 month postoperatively

  • postoperative pain

    1month, 3 month, 6 month postoperatively

  • fecal incontinence

    1month, 3 month, 6 month postoperatively

  • complication rates

    1month, 3 month, 6 month postoperatively

Study Arms (2)

LIFT

EXPERIMENTAL

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

Procedure: LIFT

LIFT-plug

EXPERIMENTAL

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure

Procedure: LIFT-plug

Interventions

LIFT-plugPROCEDURE

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure

LIFT-plug
LIFTPROCEDURE

Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure

LIFT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi’an, Shanxi, 710000, China

RECRUITING

Xi'an Jiaotong University College of Medicine

Xi’an, Shanxi, 710000, China

RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Rectal FistulaRecurrence

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Zhen Jun Wang, M.D.

    Beijing Chao Yang Hospital

    STUDY CHAIR

Central Study Contacts

Zhen Jun Wang, M.D.

CONTACT

86-1085231604wang3zj@sohu.com

Li Hua Tian, M.D.

CONTACT

86-1085231217cyky003@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 23, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

CN(5)