Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Drug: Oral antibiotic; Drug: Intravenous antibiotic; Drug: Mechanical Bowel Preparation

• Registration Number: NCT03436719
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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 Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-10
• Study First Posted: 2018-02-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral with Intravenous	Intravenous antibiotic	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
Intravenous	Intravenous antibiotic	Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Oral with Intravenous	Oral antibiotic	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
Oral with Intravenous	Mechanical Bowel Preparation	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
Intravenous	Mechanical Bowel Preparation	Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery

Primary Outcome Measures

Name	Time	Method
Rate of Surgical Site Infection	0 to 30 days

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation