Status:
UNKNOWN
Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial
Lead Sponsor:
dr. IJM Han-Geurts
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Perianal Fistula
Perianal Abscess
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Despite...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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).
Key Trial Info
Start Date :
December 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT05385887
Start Date
December 23 2021
End Date
August 1 2025
Last Update
November 13 2023
Active Locations (11)
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1
Amphia hospital
Breda, North Brabant, Netherlands, 4818 CK
2
Elisabeth-TweeSteden ziekenhuis
Tilburg, North Brabant, Netherlands, 5022 GC
3
OLVG
Amsterdam, North Holland, Netherlands, 1091 AC
4
Rode Kruis ziekenhuis
Beverwijk, North Holland, Netherlands, 1942 LE