Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial

INTRODUCTION: Perianal fistula is a burdening disease with an annual incidence of 6-12/100 000 in Western countries. More than 90% of crypto-glandular fistulas originate from perianal abscess. Despite adequate drainage, up to 83% recur or result in an anal fistula, the majority developing within 12 months. There is some evidence that gut-derived bacteria play a role in the development of perianal fistula. Up till now, it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development. There is a need for a study to establish whether adding antibiotic treatment to surgical drainage of perianal abscess results in a reduction in perianal fistulas. METHODS AND ANALYSIS: This multicentre, double-blind, randomised, placebo-controlled trial investigates whether addition of antibiotics (ciprofloxacin and metronidazole) to surgical drainage of a perianal abscess is beneficial compared with surgical drainage alone. The primary outcome is the development of a perianal fistula within 1 year. Secondary outcomes include quality of life, treatment costs, need for repeated drainage, patient-reported outcomes and other clinical outcomes. Participants are recruited in one academic and seven peripheral Dutch clinics. To demonstrate a reduction of perianal fistula from 30% to 15% when treated with adjuvant antibiotics with a two-sided alpha of 0.05, a power of 80% and taking a 10% loss to follow-up percentage into account, the total sample size will be 298 participants. Data will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers (nr. 2021_010). Written consent is obtained from each participant prior to randomisation into the study. The results of this trial will be submitted for publication in international peer-reviewed journals, presented at conferences and spread to coloproctological associations. TRIAL REGISTRATION NUMBERS: 2020-004449-35; NCT05385887.