Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract
- Conditions
- Surgical site infectionwound infection1000401810017998
- Registration Number
- NL-OMON47368
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 966
1. Adult patients (18 years of age or older)
2. Patients undergoing elective colorectal surgery.;Abovementioned patients may not meet any of the exclusion criteria
Patients who meet one or more of the following criteria will not be eligible to participate in this study:;1. Patients younger than 18 years of age
2. Legally incapacitated patients or patients who refuse to sign informed consent.
3. Patients with an inability to take oral medication
4. Patients who have undergone abdominal surgery within 30 days before randomisation
5. Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
6. Patients diagnosed with myasthenia gravis
7. Pregnant women and nursing mothers
8. Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
9. Patients with a stoma
10. Patients who already participated in the PreCaution trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine the effect of Pre-OP, in addition to<br /><br>standard perioperative intravenous antimicrobial prophylaxis, in patients<br /><br>undergoing elective colorectal surgery, on the cumulative incidence of deep SSI<br /><br>and/or mortality within 30 days after colorectal surgery. </p><br>
- Secondary Outcome Measures
Name Time Method