Perianal FistulaATLASNCT05385887
Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial
A study testing Ciprofloxacin 500 mg and Metronidazole 500 mg in people with Perianal Fistula and Perianal Abscess, run by dr. IJM Han-Geurts at 11 sites in Netherlands.
Trial summary
Rationale: Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula, Perianal Abscess, Drain Abscess
- What is being tested?
- Ciprofloxacin 500 mg and Metronidazole 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 11 sitesNetherlands
- Study dates
- 23 Dec 2021to 1 Aug 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
- Men and women aged 18 years or older
- Eligible for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Who cannot join
- A coexistent anorectal fistula
- Secondary or recurrent anorectal abscess
- Presence of an internal fistula opening
- Any additional surgical procedure performed during the same session
- Previous (peri)anal surgery
- Inflammatory bowel disease
Show all 22Show fewer
- History of radiation of the pelvic area
- Anorectal malignancy
- Immunodeficiency
- Kidney failure (eGFR <30ml/min)
- Valvular heart disease
- Pregnancy or lactation
- Postoperative antibiotic prophylaxis indicated for another reason
- Immunosuppressive medication at the time of surgery
- Allergy to metronidazole or ciprofloxacin
- Not able or trouble with swallowing pills
- Concomitant use of:
- Tizanidine, theophylline, clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine (these are all CYP1A2 substrates, ciprofloxacin is an inhibitor)
- Amiodarone, erythromycin, sotalol, azithromycin, citalopram, escitalopram, flecainide, fluconazole, haloperidol >5mg/day, methadone, ondansetron (concerning prolonged QT interval in combination with ciprofloxacin)
- Lithium (can cause toxic levels with metronidazole)
- Lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram (antabuse), mebendazole (can cause serious side effects, confusion and psychosis in combination with metronidazole)
- Corticosteroids (in combination with ciprofloxacin higher risk of tendinitis and tendon rupture).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad
Ruben Schouten, dr., ruschouten@flevoziekenhuis.nl
- Recruiting
OLVG
Amsterdam, North Holland, 1091 AC
Steve de Castro, Dr., S.M.M.deCastro@olvg.nl
- Recruiting
University Medical Center location AMC
Amsterdam
Willem M Bemelman, prof. dr.
- Recruiting
Rode Kruis ziekenhuis
Beverwijk, North Holland, 1942 LE
Frederik Jonker, Dr., fjonker@rkz.nl
- Recruiting
Proctos kliniek
Bilthoven, Utrecht, 3723 MB
Ingrid M Han-Geurts, Dr, i.han@proctoskliniek.nl
- Recruiting
Amphia hospital
Breda, North Brabant, 4818 CK
Ninos Ayez, Dr., nayez@amphia.nl
- Recruiting
IJsselland ziekenhuis
Capelle aan den IJssel
Oddeke van Ruler, dr., ovruler@ysl.nl
- Recruiting
Albert Schweitzer ziekenhuis
Dordrecht, South Holland, 3318 AT
Robert Smeenk, Dr., r.m.smeenk@asz.nl
- Recruiting
Dijklander hospital
Hoorn, North Holland, 1624 NP
Marc Govaert, Dr., m.j.p.m.govaert@dijklander.nl
- Recruiting
Elisabeth-TweeSteden ziekenhuis
Tilburg, North Brabant, 5022 GC
David Zimmerman, Dr., d.zimmerman@etz.nl
- Recruiting
Diakonessenhuis
Utrecht
Anandi Schiphorst, dr., aschiphorst@diakhuis.nl
About this study
Official title: Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial
Rationale:
Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\
Read more
Objective:
The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
Study design:
The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality.
Study population:
Men and women of 18 years and older who present for the first time with a perianal abscess.
Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets.
Main study parameters/endpoints:
Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.
- Conditions
- Perianal Fistula, Perianal Abscess, Drain Abscess
- Being tested
- Ciprofloxacin 500 mg, Metronidazole 500 mg, Placebo
- Keywords
- antibiotics, antibiotic treatment, perianal fistula, perianal abscess, drainage of abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 500 mgDrug
One tablet of 500mg Ciprifloxacine, twice a day
Metronidazole 500 mgDrug
One tablet of 500mg Metronidazole, three times a day
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Active comparator | Two kinds of antibiotics: Ciprofloxacine 500mg 2dd \& Metronidazole 500mg 3dd Receives: Drug: Ciprofloxacin 500 mg; Drug: Metronidazole 500 mg |
| Placebo | Placebo comparator | Placebo tabletes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal fistula at 1 year follow up
A perianal fistula is diagnosed based on findings from physical examination or by a telephone call after 12 months were the doctor asks for symptoms as serosanguinous discharge and pain. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed.
So: yes/no fistula (dichotomous parameter)
Measured: 1 year
Secondary outcomes (8)
Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating.
The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
Measured: 1 year
In-hospital direct and indirect costs and out-of hospital posteroperative costs
In-hospital direct and indirect costs (measured with iPCQ and iMCQ) and out-of hospital postoperative costs.
Measured: 1 year
Need of repeated drainage
Measured: 1 year
PROMs
Patient related outcome (PRO) are complaint reduction assessed by a proctology specific validated patient-related outcome measure, the proctoPROM(14). This was recently developed and validated at Proctos Clinic. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email with access to a web tool (Castor). If the patient does not have an email account, the questionnaires will be send the patients' home address, accompanied by a return envelope provided with postage stamps and the address of the hospital.
Measured: 1 year
Day of discharge from hospital
Day of discharge from hospital;
Measured: 1 year
Postoperative complications
Complications (postoperative bleeding, urinary retention requiring catheterisation, emergency reoperation, anal stenosis and fecal incontinence) including death and cause of death within 30 days will be reported using the Clavien-Dindo classification of surgical complications(15).
Measured: 1 year
Recurrent abscess
(Recurrent) abscess within one year. Yes/no (dichotomous)
Measured: 1 year
Duration of absence from work
Duration of absence from work. Amound of days is recorded (continuous scale)
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 posted23 May 2022
- Study start23 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perianal 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
- double-blind, placebo-controlled, randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. IJM Han-Geurts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. IJM Han-Geurts, Proctos Kliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385887
- Sponsor's protocol ID
- NL75540.018.20
- Other IDs
- 2020-004449-35
- Acronym
- ATLAS
- Status last verified
- Nov 2023
- First submitted
- 12 May 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A data management plan (DMP) will be composed containing the FAIR principles. Existing data will be used, and new data will be generated. Data are registered in an archive or repository and open access will be enabled. Results will be disclosed in a peer review medical journal to guarantee transparency. The study protocol was registered in an open access public trial registry before recruitment started.
Publications
van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, Han-Geurts IJM. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial. BMJ Open. 2022 Nov 8;12(11):e067970. doi: 10.1136/bmjopen-2022-067970.
PubMed 36351727
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT05385887
- Acronym / sponsor ID
- ATLAS / NL75540.018.20
- Conditions
- Perianal Fistula, Perianal Abscess, Drain Abscess
- Keywords
- antibiotics, antibiotic treatment, perianal fistula, perianal abscess, drainage of abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- dr. IJM Han-GeurtsUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 May 2022 (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.
Rationale:
Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\
Objective:
The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
Study design:
The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality.
Study population:
Men and women of 18 years and older who present for the first time with a perianal abscess.
Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets.
Main study parameters/endpoints:
Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, placebo-controlled, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | Active comparator | Drug: Ciprofloxacin 500 mg, Drug: Metronidazole 500 mgTwo kinds of antibiotics: Ciprofloxacine 500mg 2dd \& Metronidazole 500mg 3dd |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tabletes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 years or older
- Eligible for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Key exclusion criteria (22 listed)
- A coexistent anorectal fistula
- Secondary or recurrent anorectal abscess
- Presence of an internal fistula opening
- Any additional surgical procedure performed during the same session
- Previous (peri)anal surgery
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 |
|---|---|---|
| Ciprofloxacin 500 mgOne tablet of 500mg Ciprifloxacine, twice a day | Drug | Antibiotic treatment |
| Metronidazole 500 mgOne tablet of 500mg Metronidazole, three times a day | Drug | Antibiotic treatment |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Perianal fistula at 1 year follow up
Time frame: 1 year
A perianal fistula is diagnosed based on findings from physical examination or by a telephone call after 12 months were the doctor asks for symptoms as serosanguinous discharge and pain. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed. So: yes/no fistula (dichotomous parameter)
8 secondary outcomes
Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating.
Time frame: 1 year
In-hospital direct and indirect costs and out-of hospital posteroperative costs
Time frame: 1 year
Need of repeated drainage
Time frame: 1 year
PROMs
Time frame: 1 year
Day of discharge from hospital
Time frame: 1 year
Postoperative complications
Time frame: 1 year
Recurrent abscess
Time frame: 1 year
Duration of absence from work
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 13 Nov 2023.
- Derived from this study: PubMed 36351727van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, Han-Geurts IJM. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial. BMJ Open. 2022 Nov 8;12(11):e067970. doi: 10.1136/bmjopen-2022-067970.
- Individual participant dataSharing planned: Yes. A data management plan (DMP) will be composed containing the FAIR principles. Existing data will be used, and new data will be generated. Data are registered in an archive or repository and open access will be enabled. Results will be disclosed in a peer review medical journal to guarantee transparency. The study protocol was registered in an open access public trial registry before recruitment started.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofloxacin 500 mg and Metronidazole 500 mg in people with Perianal Fistula and Perianal Abscess, run by dr. IJM Han-Geurts at 11 sites in Netherlands.
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 4 inclusion and 22 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. 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?
Contact Ingrid M Han-Geurts, Dr. (030 225 0260, i.han@proctoskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perianal fistula at 1 year follow up (time frame: 1 year). 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 NCT05385887, which also lists 1 linked publication.
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 13 Nov 2023.