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

S

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
76

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

Trial contacts and locations

1

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Central trial contact

Evgeny Rybakov, Dr.Med.Sc.

Data sourced from clinicaltrials.gov

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