Anal FistulaOFFNCT03643198
Oral Antibiotics for Anal Abscess
A study testing ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) in people with Anal Fistula and Anal Abscess, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula, Anal Abscess
- What is being tested?
- ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 31 Dec 2025
- 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
- Adult patients over 18 years old
- Clinical diagnosis of perianal abscess
Who cannot join
- Participants who have a history of previous perianal abscesses.
- Inflammatory bowel disease
- Patients who already have a perianal fistula
- Patients with perianal cancer and / or pelvic radiotherapy
- Perianal trauma
- Immunodeficiency
Show all 12Show fewer
- Diabetes
- Pregnancy or lactation
- Valvular heart disease or prosthetic valve carriers
- Spontaneous drainage
- Previous use of antibiotics
- Patients with a known allergy to Ciprofloxacin or Metronidazole.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
David Parés
Barcelona, 08018
David Parés, PhD, 647423174, dapares@gmail.com
0034 497 0000 ext. 8910
About this study
Official title: Oral Antibiotics for Anal Abscess to Diminish the Developement of Perianal Fistula
BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.
Read the detailed description
METHODS This project is a 3-year study.
Trial Design:
This is a multicentre, double-blind placebo trial to investigate the effect of oral antibiotics after anal abscess drainage to diminish the development of an anal fistul.
This Clinical Trial will consist of two parallel study groups with a (1:1) randomization, masking by double-blind technique and placebo control.
Participants:
The participants of this study will be eligible among those who will be attended on the emergency department of each participant hospital during inclusion period.
Interventions:
This study will include patients who come to the emergency room due to perianal abscesses and who will be incised and drained of the lesion by local anaesthesia (in emergency boxes) or by regional or general anaesthesia (in the operating room). A standard procedure will be followed with draining the purulent contents and then instilling a solution composed of saline and iodine through the wound; as well as manual exploration and lysis of intracavity septa.
In all cases as it it standardized, the wound will be left open with insinuated gauze or a latex drainage (Penrose) when necessary.
The patients, once selected, will be randomly distributed (by specific software) in two parallel groups, in one of which the intervention will be evaluated. In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days. The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
Postoperative controls and follow-up will be carried out at 1, 3, 6 and 12 months after treatment and will include an endoanal ultrasound (US) at 6 months.
Studied variables:
The following variables will be analysed:
- Epidemiological variables: Age, gender.
- Smoking status
- Comorbidities
- Obesity (Body Mass Index)
- Cultures of abscess
- Characteristics of anal abscess: Location, type of drainage.
- Selected arm: Group treatment (antibiotics) vs. Control group (placebo)
- Clinical follow up (anal fistula or not) at 1, 3, 6 and 12 months.
The diagnosis of anal fistula is standarized by specialist in General Surgery.
- Type of anal fistula developed
- Endoanal US at 6 months
- Adverse events of treatment
- Quality of life (general health with SF-36 test and an specific test related to quality of life in patients with anal fistula, both tests validated to Spanish language) at 12 months (end of follow up)
Expected outcomes:
Once the patients with diagnosis of perianal abscess treated with incision and drainage were included, the objective of our study will be to evaluate the proportion of patients who developed perianal fistula between the two study groups (with oral antibiotics and with placebo). It will be recorded as the presence of a perianal fistula when the participants present a history of symptoms compatible with it, as well as the existence of a communication between the perianal cutaneous tissue and the anal canal during the clinical examination performed or even evidenced in the endoanal ultrasound during the controls that will be carried out up to 12 months after the intervention. For better evaluation and registration abscesses will be classified according to their complexity: subcutaneous, intersphincteric, ischiorectal and according to their anatomical location: anterior, posterior, lateral, right and left. These data will be collected at the time of the surgical exploration during the initial treatment with incision and drainage.
Fistulas will be classified by Parks classification in the following: subcutaneous, intersphinterian, transphincteric, suprasphinteric, extraphincteric. These data will be collected at the time of the clinical examination during the controls.
- Conditions
- Anal Fistula, Anal Abscess
- Being tested
- ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN), CONTROL
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN)Drug
The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
CONTROLOther
NO treatment
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Sham comparator | The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies. Receives: Other: CONTROL |
| TREATMENT | Active comparator | In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days. Receives: Drug: ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN); Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal fistula incidence
Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.
Measured: 12 months
Secondary outcomes (1)
Improving on Quality of life
Measurement of quality of life. We will use the test named SF36 in its Validated version in Spanish. This test evaluates the health-related quality of life with answers of 36 questions and punctuates from 0 to 100, being 100 the maximum score (Better quality of life).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Mar 2022
- Primary completion1 Mar 2022
- Study completion31 Dec 2025 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Parés MD, PhD, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643198
- Sponsor's protocol ID
- 2018-001-bcn.nord
- Acronym
- OFF
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2018
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antibiotics for Anal Abscess to Diminish the Developement of Perianal Fistula
- ClinicalTrials.gov ID
- NCT03643198
- Acronym / sponsor ID
- OFF / 2018-001-bcn.nord
- Conditions
- Anal Fistula, Anal Abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.
Detailed description
METHODS This project is a 3-year study.
Trial Design:
This is a multicentre, double-blind placebo trial to investigate the effect of oral antibiotics after anal abscess drainage to diminish the development of an anal fistul.
This Clinical Trial will consist of two parallel study groups with a (1:1) randomization, masking by double-blind technique and placebo control.
Participants:
The participants of this study will be eligible among those who will be attended on the emergency department of each participant hospital during inclusion period.
Interventions:
This study will include patients who come to the emergency room due to perianal abscesses and who will be incised and drained of the lesion by local anaesthesia (in emergency boxes) or by regional or general anaesthesia (in the operating room). A standard procedure will be followed with draining the purulent contents and then instilling a solution composed of saline and iodine through the wound; as well as manual exploration and lysis of intracavity septa.
In all cases as it it standardized, the wound will be left open with insinuated gauze or a latex drainage (Penrose) when necessary.
The patients, once selected, will be randomly distributed (by specific software) in two parallel groups, in one of which the intervention will be evaluated. In the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days. The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
Postoperative controls and follow-up will be carried out at 1, 3, 6 and 12 months after treatment and will include an endoanal ultrasound (US) at 6 months.
Studied variables:
The following variables will be analysed:
- Epidemiological variables: Age, gender.
- Smoking status
- Comorbidities
- Obesity (Body Mass Index)
- Cultures of abscess
- Characteristics of anal abscess: Location, type of drainage.
- Selected arm: Group treatment (antibiotics) vs. Control group (placebo)
- Clinical follow up (anal fistula or not) at 1, 3, 6 and 12 months.
The diagnosis of anal fistula is standarized by specialist in General Surgery.
- Type of anal fistula developed
- Endoanal US at 6 months
- Adverse events of treatment
- Quality of life (general health with SF-36 test and an specific test related to quality of life in patients with anal fistula, both tests validated to Spanish language) at 12 months (end of follow up)
Expected outcomes:
Once the patients with diagnosis of perianal abscess treated with incision and drainage were included, the objective of our study will be to evaluate the proportion of patients who developed perianal fistula between the two study groups (with oral antibiotics and with placebo). It will be recorded as the presence of a perianal fistula when the participants present a history of symptoms compatible with it, as well as the existence of a communication between the perianal cutaneous tissue and the anal canal during the clinical examination performed or even evidenced in the endoanal ultrasound during the controls that will be carried out up to 12 months after the intervention. For better evaluation and registration abscesses will be classified according to their complexity: subcutaneous, intersphincteric, ischiorectal and according to their anatomical location: anterior, posterior, lateral, right and left. These data will be collected at the time of the surgical exploration during the initial treatment with incision and drainage.
Fistulas will be classified by Parks classification in the following: subcutaneous, intersphinterian, transphincteric, suprasphinteric, extraphincteric. These data will be collected at the time of the clinical examination during the controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arms
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Sham comparator | Other: CONTROLThe control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies. |
| TREATMENT | Active comparator | Drug: ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN), Other: CONTROLIn the study group, patients will receive oral treatment with Ciprofloxacin at a dose of 500 mg every 12 hours and Metronidazole 500 mg every 8 hours for a period of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over 18 years old
- Clinical diagnosis of perianal abscess
Key exclusion criteria (12 listed)
- Participants who have a history of previous perianal abscesses.
- Inflammatory bowel disease
- Patients who already have a perianal fistula
- Patients with perianal cancer and / or pelvic radiotherapy
- Perianal trauma
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 |
|---|---|---|
| ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN)The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies. | Drug | TREATMENT |
| CONTROLNO treatment | Other | CONTROL, TREATMENT |
Primary outcome
Perianal fistula incidence
Time frame: 12 months
Formation of perianal/anal fistula at follow-up during 12 months after anal abscess. This outcome will be defined clinically and with anal ultrasound.
1 secondary outcome
Improving on Quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN) in people with Anal Fistula and Anal Abscess, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 2 inclusion and 12 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 14 Sep 2023. 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 Spain. 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?
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?
Perianal fistula incidence (time frame: 12 months). 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 14 Sep 2023.