EUCTR2015-005736-17-NL
Active, not recruiting
Phase 1
Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract (PreCaution trial) - PreCaution
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 966
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Adult patients (18 years of age or older) undergoing elective colorectal surgery. Elective surgery is defined as surgery for which there is no need to be performed immediately, with the possibility to be scheduled at the patient’s and surgeon’s convenience
- •\- Abovementioned patients may not meet any of the exclusion criteria
- •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 483
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 483
Exclusion Criteria
- •Patients who meet one or more of the following criteria will not be eligible to participate in this study:
- •\- Patients aged \<18 years
- •\- Legally incapacitated patients or patients who refuse to sign informed consent.
- •\- Patients with an inability to take oral medication
- •\- Patients who have undergone abdominal surgery within 30 days before randomisation
- •\- Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
- •\- Patients diagnosed with myasthenia gravis
- •\- Pregnant women and nursing mothers
- •\- Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
- •\- Patients with an ileostomy
Outcomes
Primary Outcomes
Not specified
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