Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial
NCT ID: NCT05385887
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
298 participants
INTERVENTIONAL
2021-12-23
2025-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Antibiotic treatment
Two kinds of antibiotics: Ciprofloxacine 500mg 2dd \& Metronidazole 500mg 3dd
Ciprofloxacin 500 mg
One tablet of 500mg Ciprifloxacine, twice a day
Metronidazole 500 mg
One tablet of 500mg Metronidazole, three times a day
Placebo
Placebo tabletes
Placebo
Placebo tablets
Interventions
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Ciprofloxacin 500 mg
One tablet of 500mg Ciprifloxacine, twice a day
Metronidazole 500 mg
One tablet of 500mg Metronidazole, three times a day
Placebo
Placebo tablets
Eligibility Criteria
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Inclusion Criteria
* Eligible for e-mail questionnaires
* Sufficient understanding of the Dutch written language (reading and writing)
* Obtained written informed consent
Exclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
dr. IJM Han-Geurts
OTHER
Responsible Party
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dr. IJM Han-Geurts
Principal investigator
Locations
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Amphia hospital
Breda, North Brabant, Netherlands
Elisabeth-TweeSteden ziekenhuis
Tilburg, North Brabant, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Rode Kruis ziekenhuis
Beverwijk, North Holland, Netherlands
Dijklander hospital
Hoorn, North Holland, Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, South Holland, Netherlands
Proctos kliniek
Bilthoven, Utrecht, Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
University Medical Center location AMC
Amsterdam, , Netherlands
IJsselland ziekenhuis
Capelle aan den IJssel, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Willem M Bemelman, prof. dr.
Role: primary
References
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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.
Other Identifiers
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2020-004449-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL75540.018.20
Identifier Type: -
Identifier Source: org_study_id
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