Antibiotics after drainage of perianal abscess to avoid fistula formatio

Phase 1

• Conditions: Abscess and anal fistulas; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2019-001002-18-ES
• Lead Sponsor: Hospital Universitari Germans Trias i Pujol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

18 years or more
Both genders
Clinical diagnosis of anal abscess (acute inflammatory signs and presence of a purulent collection in the perianal area) seen or confirmed through punction aspiration of purulent material with needle.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Inflammatory bowel disease
Anal surgical history
Anal fistula alredy konwn
Anal carcinoma and/or pelvic radiotherapy
Anal trauma history
horse shoe abscess
Inmunodeficiency, diabetes, pregnancy or lactation, heart valve disease or prosthetic valve carriers
Spontaneous drainage of abscess
Antibiotics use
Contraindications of ciprofloxacin according to SPC (hypersensitivity to the active principle, or to other quinolones or to any of the excipients; concomitant administration of ciprofloxacin and tizanidine)
- Contraindications of metronidazole according to SPC (hypersensitivity to imidazoles or to any of the excipients)
-Pregnancy and lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate that oral antibiotic after perianal abscess debridement decreases the anal fistula incidence;Secondary Objective: Show the clinical benefit (quality of life included) of oral antibiotic after perianal abscess debridement in development of anal fistula<br>Describe the pacients under risk of anal fistulas aparition after anal abscess episode.;Primary end point(s): Fistula anal presence (Parks classification);Timepoint(s) of evaluation of this end point: 1st month<br>3rd month<br>6th month<br>9th month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ultrasonography to fistula examination;Timepoint(s) of evaluation of this end point: 6th months