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Clinical Trials/EUCTR2020-004449-35-NL
EUCTR2020-004449-35-NL
Active, not recruiting
Phase 1

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

ZonMw0 sites298 target enrollmentMarch 26, 2021
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DrugsMetronidazole and ciprofloxacin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ZonMw
Enrollment
298
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 26, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ZonMw

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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