Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Overview
- Phase
- Not Applicable
- Intervention
- Oral antibiotic
- Conditions
- Rectal Cancer
- Sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Rate of Surgical Site Infection
- Last Updated
- 7 years ago
Overview
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.
Investigators
Rybakov Evgeny, MD
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
State Scientific Centre of Coloproctology, Russian Federation
Eligibility Criteria
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 .
Arms & Interventions
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Oral antibiotic
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Intravenous antibiotic
Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Mechanical Bowel Preparation
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Intravenous antibiotic
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Mechanical Bowel Preparation
Outcomes
Primary Outcomes
Rate of Surgical Site Infection
Time Frame: 0 to 30 days