NCT00487071

Brief Summary

The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

7.5 years

First QC Date

June 13, 2007

Last Update Submit

February 12, 2014

Conditions

High-type Anal Fistulae

Keywords

Anal fistulaHigh-typeAnal fistula plugEfficacyRecurrence

Outcome Measures

Primary Outcomes (1)

  • Fistula healing rate and time for fistula closure

    Up to 1 year

Secondary Outcomes (2)

  • Fistula recurrence rate

    Up to 1 year

  • Morbidity

    Up to 1 year

Study Arms (1)

Anal fistula plug

EXPERIMENTAL
Device: Anal fistula plug

Interventions

Anal fistula plugDEVICE
Anal fistula plug

Eligibility Criteria

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

You may qualify if:

  • Patients with high-type anal fistulae confirmed by MRI
  • Informed consent available

You may not qualify if:

  • Patients with previous fistula surgery
  • Patients with Crohn's disease
  • Patients allergic to porcine material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong SAR, China

Location

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

  • Simon SM Ng, FRCSEd (Gen)

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Study Start

August 1, 2006

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

CN(1)