Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Marmara University
Sponsor:
Information provided by (Responsible Party):
M.Umit UGURLU, Marmara University
ClinicalTrials.gov Identifier:
NCT01929525
First received: August 19, 2013
Last updated: August 22, 2013
Last verified: August 2013
  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 Marmara University:

Primary Outcome Measures:
  • Number of anal fistula patients treated with silver nitrate solution. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: M.Umit UGURLU, Assistant profesor of surgery, Marmara University
ClinicalTrials.gov Identifier: NCT01929525     History of Changes
Other Study ID Numbers: MarmaraUSM
Study First Received: August 19, 2013
Last Updated: August 22, 2013
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Intestinal Fistula
Digestive System Fistula
Pathological Conditions, Anatomical
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Silver Nitrate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014