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

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.

Full Title of Study: “Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2020

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.

Interventions

  • Drug: Oral antibiotic
    • 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
  • Drug: Intravenous antibiotic
    • Cefoperazone – 1000 mg intravenously for 30-90 minutes before surgery
  • Drug: Mechanical Bowel Preparation
    • Beginning of MBP at 4 p.m. in a day before surgery

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: Intravenous
    • Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Surgical Site Infection
    • Time Frame: 0 to 30 days

Participating in This Clinical Trial

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 .

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • State Scientific Centre of Coloproctology, Russian Federation
  • Provider of Information About this Clinical Study
    • Principal Investigator: 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
  • Overall Contact(s)
    • Evgeny Rybakov, Dr.Med.Sc., +7 499 199 86 43, erybakov@gmail.com

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