Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

July 25, 2019 updated by: Central Finland Hospital District

Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.

Study Type

Observational

Enrollment (Actual)

60

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

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Joensuu, Finland
        • Central Hospital
      • Jyväskylä, Finland
        • Central Hospital
      • Lahti, Finland
        • Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Seinäjoki, Finland
        • Central Hospital
      • Turku, Finland
        • Turku University Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inhabitants of Finland

Description

Inclusion Criteria:

  • Age 18-70 years, male or female
  • High cryptoglandular perianal fistula
  • Written approval for the study
  • Sufficient co-operation for the study
  • Localization of the fistula by ultrasound or MRI

Exclusion Criteria:

  • Crohns disease
  • Immunosuppressive treatment
  • Anovaginal fistula
  • Radiation therapy 6 months before study
  • Chemotherapy 6 months before study
  • Low- or intersphincteric fistula

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fistula patients
Gore-BioA Fistula Plug
Procedure: Gore-BioA Fistula Plug
Gore-BioA Fistula Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing of the fistula
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms of fecal incontinence
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Central Finland Hospital District

Investigators

  • Study Director: Matti V Kairaluoma, ph.D, Central Hospital, Jyväskylä, Finland

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

November 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSSHP1U/2011

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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