Anal FistulaNCT01929525
Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula
An observational study of Anal Fistula, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Anal Fistula
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of anal fistula
Who may be able to join
- All patients with the diagnosis of anal fistula Patients with recurrence
Who cannot join
- Patients who do not sign the informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
MarmaraUSM
Istanbul, Istanbul, 34893
M.Unit Ugurlu, MD, +905324108010, umitugurlu@gmail.com
M.Umit Ugurlu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Anal Fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of anal fistula patients treated with silver nitrate solution.
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
Measured: 1 year
Secondary outcomes (1)
Therapeutic factors
The secondary end point was to identify the clinical and therapeutic factors that significantly affect the primary endpoint.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.Umit UGURLU, Marmara University
- Investigators
- S.CUMHUR YEGEN, MD, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929525
- Sponsor's protocol ID
- MarmaraUSM
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula: A Novel Strategy for Managing Anal Fistula
- ClinicalTrials.gov ID
- NCT01929525
- Acronym / sponsor ID
- MarmaraUSM
- Conditions
- Anal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of anal fistula
Key inclusion criteria (1 listed)
- All patients with the diagnosis of anal fistula Patients with recurrence
Key exclusion criteria (1 listed)
- Patients who do not sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Therapeutic factors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S.CUMHUR YEGEN, MD study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anal fistula patients treated with silver nitrate solution. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.