Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial

Launched by DR. IJM HAN-GEURTS · May 17, 2022

Keywords

ClinConnect Summary

The ATLAS Trial is studying whether adding antibiotics to the surgical drainage treatment of a perianal abscess can help reduce the chances of developing a perianal fistula. A perianal abscess is a painful collection of pus near the anus, and when it is not treated effectively, it can lead to further complications, including fistulas. This trial is open to men and women aged 18 and older who are experiencing their first perianal abscess. Participants will be randomly assigned to receive either the usual surgical drainage along with antibiotics or a placebo (a pill that looks like the antibiotic but has no active ingredients).

If you choose to participate, you won’t need to make extra trips to the hospital; you’ll only need to complete some questionnaires via email at the start of the study, and then again at several points over the next year. These questionnaires will take about 10 minutes each time and will help researchers gather information about your recovery and quality of life. It’s important to be aware that there are certain medical conditions and medications that could prevent you from participating, so a thorough screening will be done to ensure eligibility. Your involvement could help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility 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).