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Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula

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ClinicalTrials.gov Identifier: NCT01929525
Recruitment Status : Unknown
Verified August 2013 by M.Umit UGURLU, Marmara University.
Recruitment status was:  Recruiting
First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
M.Umit UGURLU, Marmara University

Brief Summary:
Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.

Condition or disease
Anal Fistula

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort
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.



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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


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
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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
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Study Chair: S.CUMHUR YEGEN, MD Marmara University

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Responsible Party: M.Umit UGURLU, Assistant profesor of surgery, Marmara University
ClinicalTrials.gov Identifier: NCT01929525     History of Changes
Other Study ID Numbers: MarmaraUSM
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Silver Nitrate
Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Anti-Infective Agents, Local
Anti-Infective Agents