Anal FistulaNCT01012843
Do Antibiotics Prevent Anal Fistulae Formation?
A study testing Amoxicillin-Clavulanate in people with Anal Fistula, run by Ankara University at 3 sites in Turkey (Türkiye).
Trial summary
Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses. Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Amoxicillin-Clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Sep 2005to Jan 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of anorectal abscess
Who cannot join
- Allergy to penicillin derivatives
- Treatment with any antimicrobial agent in the week before enrolment
- Recognized other infection at the time of surgery
- Previous anorectal surgery
- Presence of inflammatory bowel disease
- Suspicion of Fournier's gangrene
Show all 15Show fewer
- Secondary and recurrent anorectal abscesses
- Presence of an internal opening
- Any additional surgical procedure performed in the same session or during follow-up
- Antibiotic prophylaxis indicated for another reason
- Immunosuppressive and/or anticoagulant drug treatment being taken at the time of surgery
- Diabetes mellitus
- Known chronic disabling disease
- Pregnancy
- Lactation.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Ankara Numune Teaching and Research Hospital
Ankara, 06100
Ankara University School of Medicine Department Of General Surgery
Ankara, 06100
Dicle University School of Medicine
Diyarbakır
About this study
Official title: Does Adjuvant Antibiotic Treatment After Drainage of Anorectal Abscess Prevent the Development of Anal Fistulae? A Prospective Randomized, Placebo Controlled, Double Blind, Multi-Center Clinical Study
Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses.
Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.
- Conditions
- Anal Fistula
- Being tested
- Amoxicillin-Clavulanate, Placebo
- Keywords
- Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal
- Medical subject headings
- Rectal Fistula, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-ClavulanateDrug
Also called Bioment 1 gr BID tablets
oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days
PlaceboDrug
oral Placebo tablets two times a day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic | Active comparator | Patients who received antibiotic treatment after abscess drainage Receives: Drug: Amoxicillin-Clavulanate |
| Placebo | Placebo comparator | Patients who received placebo after abscess drainage Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula formation
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Investigators
- Ulas Sozener, M.D., Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012843
- Sponsor's protocol ID
- AUTF-001
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 16 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vasilevsky CA, Gordon PH. The incidence of recurrent abscesses or fistula-in-ano following anorectal suppuration. Dis Colon Rectum. 1984 Feb;27(2):126-30. doi: 10.1007/BF02553995.
PubMed 6697831Nunoo-Mensah JW, Balasubramaniam S, Wasserberg N, Artinyan A, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr, Vukasin P. Fistula-in-ano: do antibiotics make a difference? Int J Colorectal Dis. 2006 Jul;21(5):441-3. doi: 10.1007/s00384-005-0022-4. Epub 2005 Aug 10.
PubMed 16091913Hamalainen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. doi: 10.1007/BF02237048.
PubMed 9823799Ramanujam PS, Prasad ML, Abcarian H, Tan AB. Perianal abscesses and fistulas. A study of 1023 patients. Dis Colon Rectum. 1984 Sep;27(9):593-7. doi: 10.1007/BF02553848.
PubMed 6468199
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adjuvant Antibiotic Treatment After Drainage of Anorectal Abscess Prevent the Development of Anal Fistulae? A Prospective Randomized, Placebo Controlled, Double Blind, Multi-Center Clinical Study
- ClinicalTrials.gov ID
- NCT01012843
- Acronym / sponsor ID
- AUTF-001
- Conditions
- Anal Fistula
- Keywords
- Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Nov 2009 (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.
Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses.
Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Active comparator | Drug: Amoxicillin-ClavulanatePatients who received antibiotic treatment after abscess drainage |
| Placebo | Placebo comparator | Drug: PlaceboPatients who received placebo after abscess drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of anorectal abscess
Key exclusion criteria (15 listed)
- Allergy to penicillin derivatives
- Treatment with any antimicrobial agent in the week before enrolment
- Recognized other infection at the time of surgery
- Previous anorectal surgery
- Presence of inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-ClavulanateAlso: Bioment 1 gr BID tabletsoral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days | Drug | Antibiotic |
| Placebooral Placebo tablets two times a day for 10 days | Drug | Placebo |
Primary outcome
Fistula formation
Time frame: 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2009.
- Background: PubMed 6697831Vasilevsky CA, Gordon PH. The incidence of recurrent abscesses or fistula-in-ano following anorectal suppuration. Dis Colon Rectum. 1984 Feb;27(2):126-30. doi: 10.1007/BF02553995.
- Results publication: PubMed 16091913Nunoo-Mensah JW, Balasubramaniam S, Wasserberg N, Artinyan A, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr, Vukasin P. Fistula-in-ano: do antibiotics make a difference? Int J Colorectal Dis. 2006 Jul;21(5):441-3. doi: 10.1007/s00384-005-0022-4. Epub 2005 Aug 10.
- Results publication: PubMed 9823799Hamalainen KP, Sainio AP. Incidence of fistulas after drainage of acute anorectal abscesses. Dis Colon Rectum. 1998 Nov;41(11):1357-61; discussion 1361-2. doi: 10.1007/BF02237048.
- Results publication: PubMed 6468199Ramanujam PS, Prasad ML, Abcarian H, Tan AB. Perianal abscesses and fistulas. A study of 1023 patients. Dis Colon Rectum. 1984 Sep;27(9):593-7. doi: 10.1007/BF02553848.
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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.
Ulas Sozener, M.D. study chair
Ankara University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin-Clavulanate in people with Anal Fistula, run by Ankara University at 3 sites 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 15 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: finished, as of the sponsor's last update on 16 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula formation (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01012843, which also lists 4 linked publications.
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 16 Nov 2009; AzTrials last refreshed its copy on 1 Nov 2026.