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

State Scientific Centre of Coloproctology, Russian Federation280 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

280

Conditions

Rectal Cancer

Interventions

Oral antibioticDRUG

Metronidazole - 500 mg and Erythromycin - 500 mg per os \*3 times at 5 p.m.; 8 p.m., 11 p.m. in a day before surgery

Intravenous antibioticDRUG

Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery

Mechanical Bowel PreparationDRUG

Beginning of MBP at 4 p.m. in a day before surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 .

Locations (1)

State Scientific Centre of Coloproctology

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

Rate of Surgical Site Infection

Time frame: 0 to 30 days

Central Contacts

Evgeny Rybakov, Dr.Med.Sc.

CONTACT

+7 499 199 86 43 erybakov@gmail.com

Data from ClinicalTrials.gov

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