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Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by M.Umit UGURLU, Marmara University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01929525
First Posted: August 28, 2013
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.Umit UGURLU, Marmara University
  Purpose
Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.

Condition
Anal Fistula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula: A Novel Strategy for Managing Anal Fistula

Resource links provided by NLM:


Further study details as provided by M.Umit UGURLU, Marmara University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Therapeutic factors [ Time Frame: 1 year ]
    The secondary end point was to identify the clinical and therapeutic factors that significantly affect the primary endpoint.


Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the diagnosis of anal fistula
Criteria

Inclusion Criteria:

All patients with the diagnosis of anal fistula Patients with recurrence

Exclusion Criteria:

Patients who do not sign the informed consent

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929525


Locations
Turkey
MarmaraUSM Recruiting
Istanbul, Turkey, 34893
Contact: M.Unit Ugurlu, MD    +905324108010    umitugurlu@gmail.com   
Sub-Investigator: M.Umit Ugurlu, MD         
Sponsors and Collaborators
Marmara University
Investigators
Study Chair: S.CUMHUR YEGEN, MD Marmara University
  More Information

Responsible Party: M.Umit UGURLU, Assistant profesor of surgery, Marmara University
ClinicalTrials.gov Identifier: NCT01929525     History of Changes
Other Study ID Numbers: MarmaraUSM
First Submitted: August 19, 2013
First Posted: August 28, 2013
Last Update Posted: August 28, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Silver Nitrate
Anti-Infective Agents, Local
Anti-Infective Agents