Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial.

Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial. - ATLAS trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54272

Enrollment

298

Registered

2021-03-22

Start date

2021-12-23

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fistula fistula in ano

Interventions

Patients were randomly allocated to 1 of 2 groups (antibiotics or placebo). The antibiotic group received 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twel

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Men and women aged 18 years or older - Presenting for the first time with a perianal abscess - Eligible for e-mail questionnaires - Sufficient understanding of the Dutch written language (reading and writing) - Obtained written informed consent

Exclusion criteria

Exclusion criteria: -a coexistent perianal fistula, -secondary or recurrent perianal 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 5mg/day, methadone, ondansetron (concerning prolonged QT interval in combination with ciprofloxacin) o Lithium (can cause toxic levels with metronidazole) o Lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram (antabuse), mebendazole (can cause serious side effects, confusion and psychosis in combination with metronidazole) o Corticosteroids (in combination with ciprofloxacin higher risk of tendinitis and tendon rupture).

Design outcomes

Primary

Measure	Time frame
Primary outcome measure is development of a perianal fistula. A perianal fistula is diagnosed based on findings from physical examination. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed.	—

Secondary

Measure	Time frame
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 (measured with IPCQ and iMCQ) and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. Patient-related outcomes are complaint reduction assessed by a Proctology specific validated patient-related outcome measure (PROM) this was recently developed and validated at Proctos Clinic (Vander Mijnsbrugge). Operatie data, klinische uitkomsten (complicaties, day of discharge, complications, readmission, dureation of absence of work).	—

Measure

Time frame

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 (measured with IPCQ and iMCQ) and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. Patient-related outcomes are complaint reduction assessed by a Proctology specific validated patient-related outcome measure (PROM) this was recently developed and validated at Proctos Clinic (Vander Mijnsbrugge). Operatie data, klinische uitkomsten (complicaties, day of discharge, complications, readmission, dureation of absence of work).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)