NCT05385887: ATLAS

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

Status unknown NA Last updated 13 November 2023

What this trial tests

NA trial testing Ciprofloxacin 500 mg in Perianal Fistula in 298 participants. Status unknown.

Timeline

23 December 2021

Primary endpoint
31 December 2024

1 August 2025

Quick facts

Lead sponsor	dr. IJM Han-Geurts
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	298
Start date	23 December 2021
Primary completion	31 December 2024
Estimated completion	1 August 2025
Sites	11 locations across Netherlands

Drugs / interventions tested

• Ciprofloxacin 500 mg — full drug profile →
• Metronidazole 500 mg — full drug profile →
• Placebo

Conditions studied

• Perianal Fistula — all drugs for Perianal Fistula →
• Perianal Abscess — all drugs for Perianal Abscess →
• Drain Abscess — all drugs for Drain Abscess →

Sponsor

dr. IJM Han-Geurts

Who can join

18 and older, any sex, with Perianal Fistula or Perianal Abscess. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antibiotic Treatment foLlowing surgical drAinage of perianal abScess (ATLAS): protocol for a multicentre, double-blind, placebo-controlled, randomised trial.
   van Oostendorp JY, Dekker L, van Dieren S, Bemelman WA, et al · · 2022 · cited 5× · PMID 36351727 · DOI 10.1136/bmjopen-2022-067970