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

State Scientific Centre of Coloproctology, Russian Federation

Status

Unknown

Conditions

Rectal Cancer

Treatments

Drug: Intravenous antibiotic

Drug: Oral antibiotic

Drug: Mechanical Bowel Preparation

Study type

Interventional

Funder types

Other

Identifiers

NCT03436719

Details and patient eligibility

About

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.

Full 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.

Enrollment

280 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 .

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

Oral with Intravenous

Experimental group

Description:

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

Treatment:

Drug: Mechanical Bowel Preparation

Drug: Oral antibiotic

Drug: Intravenous antibiotic

Intravenous

Active Comparator group

Description:

Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery

Treatment:

Drug: Mechanical Bowel Preparation

Drug: Intravenous antibiotic