Rectal Cancer
Conditions
Keywords
Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis
Brief summary
This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.
Detailed description
Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.
Interventions
DRUGOral antibiotic
Metronidazole - 500 mg and Erythromycin - 500 mg per os \*3 times at 5 p.m.; 8 p.m., 11 p.m. in a day before surgery
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Beginning of MBP at 4 p.m. in a day before surgery
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a planned of resection of rectum * Have signed approved informed consent form for the study.
Exclusion criteria
* Significant simultaneous surgical procedure (e.g., liver resection of metastasis) * Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery * Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min) * Allergy on the study drugs .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Surgical Site Infection | 0 to 30 days |
Countries
Russia
Contacts
Primary ContactEvgeny Rybakov, Dr.Med.Sc.
Outcome results
None listed