- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01021774
Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery
November 28, 2016 updated by: Tom Oresland, University Hospital, Akershus
Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Perianal fistula can occur as a complication to a perianal abscess.
A perianal fistula is associated with significant morbidity and reduced quality of life.
Anal fistulas seldom heal spontaneously and may require surgical intervention.
The main purpose of the operation will be to close the fistula and preserve anal continence.
The traditional surgical fistula closing techniques often show disappointing results.
Today, a collagen plug for fistula treatment is commercially available.
The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap).
The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain.
Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
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
-
-
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Lorenskog, Norway, 1478
- Akershus University Hospital
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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 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with fistula involving > 1/3 of the external anal sphincter
- Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
- Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
- All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up
Exclusion Criteria:
- Fistula tract shorter than 2 cm
- Complex fistula tract system (branching of the fistula tract)
- Age < 18 years
- Pregnancy
- HIV-positivity
- Fistula caused by malignancy
- Tuberculosis
- Hidrosadenitis suppurativa
- Pilonidal sinus disease
- No internal fistula opening found
- Unable/contra indications to go through MRI scanning
- Crohn´s disease
- Ulcerative proctitis
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
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Advancement flap surgery
|
A comparison of collagen plug vs advancement flap surgery
Other Names:
|
ACTIVE_COMPARATOR: Collagen plug
|
A comparison of collagen plug vs advancement flap surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anorectal fistula closing rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2009
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
November 27, 2009
First Submitted That Met QC Criteria
November 27, 2009
First Posted (ESTIMATE)
November 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-08493(REK)
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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