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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 298

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

-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 <30ml/min
-valvular heart disease,
-pregnancy or lactation,
-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:
o Tizanidine, theophylline, clozapine, olanzapine, pirfenidone, carbamazepine,
agomelatine (these are all CYP1A2 substrates, ciprofloxacin is an inhibitor)
o Amiodarone, erythromycin, sotalol, azithromycin, citalopram, escitalopram,
flecainide, fluconazole, haloperidol >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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is development of a perianal fistula. A perianal<br /><br>fistula is diagnosed based on<br /><br>findings from physical examination. An external opening with or without<br /><br>serosanguilent discharge is<br /><br>considered a fistula. In case of doubt an endoanal ultrasonography or MRI is<br /><br>performed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are quality of life at 12 months measured with the<br /><br>EQ-5D-5L with Dutch<br /><br>rating. Further: in-hospital direct and indirect costs (measured with IPCQ<br /><br>and iMCQ) and out-of hospital postoperative costs, need of repeated drainage,<br /><br>patient related outcome<br /><br>(PRO) and clinical outcome measures. Patient-related outcomes are complaint<br /><br>reduction assessed by a<br /><br>Proctology specific validated patient-related outcome measure (PROM) this was<br /><br>recently developed and<br /><br>validated at Proctos Clinic (Vander Mijnsbrugge). Operatie data, klinische<br /><br>uitkomsten (complicaties, day of discharge, complications, readmission,<br /><br>dureation of absence of work).</p><br>

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