The medical condition under investigation: surgical site infections (bacterial) after elective colorectal surgery. MedDRA version: 19.0 Level: LLT Classification code 10053562 Term: Surgical wound infection System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10056641 Term: Post procedural site wound infection
Conditions
Interventions
Product Name: SDD voor darmchirurgie
Product Code: 16059670
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLISTIN SULFATE
CAS
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion 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
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 - Patients who already participated in the PreCaution trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is a composite endpoint, consisting of: deep surgical site infection and/or mortality ;Timepoint(s) of evaluation of this end point: 30 days after elective surgery;Main Objective: The primary objective is to determine the effect of preoperative oral antibiotic prophylaxis (Pre-OP), in addition to standard perioperative intravenous antimicrobial prophylaxis, in patients undergoing elective colorectal surgery, on the cumulative incidence of deep SSI and/or mortality within 30 days after colorectal surgery. ; Secondary Objective: 1. To determine the effect of Pre-OP, in addition to standard perioperative intravenous antibiotic prophylaxis, in patients undergoing elective colorectal surgery on: a) The cumulative incidence of superficial incisional SSI within b) The cumulative incidence of anastomotic leakage (AL) c) The all-cause mortality d) The cumulative incidence of relaparotomy e) The cumulative incidence of bacteraemia f) The cumulative incidence of infections i. Highly-resistant micro-organisms (HRMO) ii. Clostridium difficile g) The postoperative length of hospital stay, including readmissions h) The postoperative length of ICU stay, including readmissions i) The in-hospital costs j) The in-hospital use of antibiotics k) The quality of life 2. To identify risk factors for SSI and assess whether these are dependent on: a) The type of surgery (e.g. colon versus rectum) b) The use of Pre-OP (active study medication versus placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days after elective colorectal surgery (endpoint 1,2,4-7,10) 6 months after elective colorectal surgery (endpoint 3,8,9,11,12) ; Secondary end point(s): 1. The cumulative incidence of superficial incisional SSI 2. The cumulative incidence of anastomotic leakage 3. The all-cause mortality 4. The cumulative incidence of relaparotomy 5. The cumulative incidence of bacteraemia 6. The cumulative incidence of infections with: - Highly-resistant Enterobacteriaceae (HRE) - Clostridium difficile 7. The presence of HRE in the intestinal flora 8. The postoperative length of hospital stay, including readmissions 9. The postoperative length of ICU stay, including readmissions 10. The in-hospital use of antibiotics 11. The in-hospital costs 12. The quality of life | — |
Countries
Netherlands
Contacts
Public ContactDrs. Tessa Mulder
University Medical Center Utrecht
Outcome results
None listed