Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
NCT ID: NCT03436719
Last Updated: 2019-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2017-11-06
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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
Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Interventions
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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
Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have signed approved informed consent form for the study.
Exclusion Criteria
* 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 .
18 Years
ALL
No
Sponsors
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State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
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Rybakov Evgeny, MD
Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
Locations
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State Scientific Centre of Coloproctology
Moscow, , Russia
Countries
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Central Contacts
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Other Identifiers
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76
Identifier Type: -
Identifier Source: org_study_id
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