Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Rate of Surgical Site Infection
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 .
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 (Drug)
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 (Drug)
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 (Drug)
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Intravenous antibiotic (Drug)
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention: Mechanical Bowel Preparation (Drug)
Outcomes
Primary Outcomes
Rate of Surgical Site Infection
Time Frame: 0 to 30 days
Secondary Outcomes
No secondary outcomes reported
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