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Trial record 77 of 179 for:    ERYTHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT03436719
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Rybakov Evgeny, MD, 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Oral antibiotic Drug: Intravenous antibiotic Drug: Mechanical Bowel Preparation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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
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
Other Names:
  • Metronidazole
  • Erythromycin

Drug: Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Other Name: Cefoperazone

Drug: Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Other Name: polyethylene glycol

Active Comparator: Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Drug: Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Other Name: Cefoperazone

Drug: Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Other Name: polyethylene glycol




Primary Outcome Measures :
  1. Rate of Surgical Site Infection [ Time Frame: 0 to 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436719


Contacts
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Contact: Evgeny Rybakov, Dr.Med.Sc. +7 499 199 86 43 erybakov@gmail.com

Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation

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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03436719     History of Changes
Other Study ID Numbers: 76
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation:
Surgical Site Infection
Rectal Cancer Surgery
Oral Antibiotic
Antibiotic Prophylaxis
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Metronidazole
Cefoperazone
Antibiotics, Antitubercular
Sulperazone
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents