- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929525
Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula
August 22, 2013 updated by: M.Umit UGURLU, Marmara University
Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula: A Novel Strategy for Managing Anal Fistula
Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.
Study Overview
Status
Unknown
Conditions
Detailed Description
The anal fistula is a granulation tissue-lined tract, we thought of a way to ablate this granulation tissue using a chemical agent, which would eventually induce healing with fibrosis and closure of the tract without any surgical intervention.
Aiming to reduce the surgery related complications; we investigated the effectiveness of silver nitrate solution as a chemical agent in the treatment of anal fistula.
Study Type
Observational
Enrollment (Anticipated)
70
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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Istanbul, Turkey, 34893
- Recruiting
- MarmaraUSM
-
Contact:
- M.Unit Ugurlu, MD
- Phone Number: +905324108010
- Email: umitugurlu@gmail.com
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Sub-Investigator:
- M.Umit Ugurlu, MD
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients with the diagnosis of anal fistula
Description
Inclusion Criteria:
All patients with the diagnosis of anal fistula Patients with recurrence
Exclusion Criteria:
Patients who do not sign the informed consent
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Silver Nitrate
Irrigation of fistula tract with 1% silver nitrate solution for all patients who accepts the study and signed the written informed consent form.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of anal fistula patients treated with silver nitrate solution.
Time Frame: 1 year
|
The primary end point in the study was to assess the efficacy of the silver nitrate in the treatment of anal fistula.
The number of anal fistula patients who are treated with silver nitrate solution will be calculated.
The role of silver nitrate solution in anal fistula treatment will be investigated
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic factors
Time Frame: 1 year
|
The secondary end point was to identify the clinical and therapeutic factors that significantly affect the primary endpoint.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: S.CUMHUR YEGEN, MD, Marmara University
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
August 1, 2013
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 22, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Estimate)
August 28, 2013
Last Update Submitted That Met QC Criteria
August 22, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MarmaraUSM
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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