Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

• Sponsor: Central Finland Hospital District (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01584752
• Collaborator: (none)
• Enrollment: 60
• Locations: 7
• Duration (Months): 48
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Anal Fistula; Fecal Incontinence; Surgery	Procedure: Gore-BioA Fistula Plug

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Fistula patients Gore-BioA Fistula Plug	Procedure: Gore-BioA Fistula Plug; Gore-BioA Fistula Plug

Outcome Measures

Primary Outcome Measures

1. Healing of the fistula [6 months]

Secondary Outcome Measures

1. Symptoms of fecal incontinence [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland
2	Central Hospital	Joensuu		Finland
3	Central Hospital	Jyväskylä		Finland
4	Central Hospital	Lahti		Finland
5	Oulu University Hospital	Oulu		Finland
6	Central Hospital	Seinäjoki		Finland
7	Turku University Hospital	Turku		Finland

Sponsors and Collaborators

• Central Finland Hospital District

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Finland Hospital District
• ClinicalTrials.gov Identifier: NCT01584752
• Other Study ID Numbers: KSSHP1U/2011
• First Posted: Apr 25, 2012
• Last Update Posted: Jul 26, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Fecal Incontinence; Rectal Fistula; Fistula

Study Results

No Results Posted as of Jul 26, 2019