Antibiotic treatment following surgical drainage of perianal abscess.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 298

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 298
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-A coexistent perianal fistula
-Spontaneous drainage
-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: tizadine, theopylline clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine, amiodarone, erytromcyine, sotalol, azithormycine, citalopram, escitalopram, flecainide, fluconazol, haloperidol >5mg/day, methadone, ondansetron, lithium, lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram, mebendazole, corticosteroids

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas. ;Secondary Objective: Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. In-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method

Related Trials