Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01584752
• Other study ID #: KSSHP1U/2011
• Status: Terminated
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2019
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fecal Incontinence
• Fistula
• Rectal Fistula
• Surgery

Intervention

Procedure:
• Gore-BioA Fistula Plug
Gore-BioA Fistula Plug

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Central Hospital	Joensuu
Finland	Central Hospital	Jyväskylä
Finland	Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Central Hospital	Seinäjoki
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of the fistula		6 months
Secondary	Symptoms of fecal incontinence		6 months