Antibiotic treatment after draining perianal abscesses
Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial
This study tests if giving antibiotics after draining perianal abscesses can help prevent the development of perianal fistulas in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 298 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Proctos Kliniek Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Tilburg, Noord-Brabant and 10 other locations) |
| Trial ID | NCT05385887 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether adding antibiotic treatment to the surgical drainage of perianal abscesses can reduce the incidence of perianal fistulas. It is a double-blind, placebo-controlled, randomized, multicenter trial involving patients with a primary occurrence of perianal abscess. Participants will be randomly assigned to receive either antibiotics or a placebo following their surgical procedure. The study aims to provide evidence on the effectiveness of prophylactic antibiotics in preventing complications after abscess drainage.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 18 years or older who are experiencing a primary perianal abscess.
Not a fit: Patients with a coexisting anorectal fistula or those with recurrent abscesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the recurrence of perianal fistulas in patients who have undergone abscess drainage.
How similar studies have performed: While the use of antibiotics in similar contexts has been explored, this specific approach to preventing perianal fistulas following abscess drainage is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Tilburg, Noord-Brabant and 10 other locations
- Elisabeth-TweeSteden ziekenhuis — Tilburg, Noord-Brabant, Netherlands (Recruiting)
- Rode Kruis ziekenhuis — Beverwijk, Noord-Holland, Netherlands (Recruiting)
- Amphia hospital — Breda, North-Brabant, Netherlands (Recruiting)
- Olvg — Amsterdam, North-Holland, Netherlands (Recruiting)
- Dijklander hospital — Hoorn, North-Holland, Netherlands (Recruiting)
- Proctos kliniek — Bilthoven, Utrecht, Netherlands (Recruiting)
- Albert Schweitzer ziekenhuis — Dordrecht, Zuid-Holland, Netherlands (Recruiting)
- Flevoziekenhuis — Almere, Netherlands (Recruiting)
- University Medical Center location AMC — Amsterdam, Netherlands (Recruiting)
- IJsselland ziekenhuis — Capelle Aan Den IJssel, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Ingrid M Han-Geurts, Dr.
- Email: i.han@proctoskliniek.nl
- Phone: 030 225 0260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.