Back to resultsAntibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Oral antibiotic
Intravenous antibiotic
Mechanical Bowel Preparation
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer focused on measuring Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis
Eligibility 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 .
Sites / Locations
- State Scientific Centre of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral with Intravenous
Intravenous
Arm 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
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Outcomes
Primary Outcome Measures
Rate of Surgical Site Infection
Secondary Outcome Measures
Full Information
NCT ID
NCT03436719
First Posted
February 5, 2018
Last Updated
March 4, 2019
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT03436719
Brief Title
Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Official Title
Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral with Intravenous
Arm Type
Experimental
Arm 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
Arm Title
Intravenous
Arm Type
Active Comparator
Arm Description
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Intervention Type
Drug
Intervention Name(s)
Oral antibiotic
Other Intervention Name(s)
Metronidazole, Erythromycin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intravenous antibiotic
Other Intervention Name(s)
Cefoperazone
Intervention Description
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Intervention Type
Drug
Intervention Name(s)
Mechanical Bowel Preparation
Other Intervention Name(s)
polyethylene glycol
Intervention Description
Beginning of MBP at 4 p.m. in a day before surgery
Primary Outcome Measure Information:
Title
Rate of Surgical Site Infection
Time Frame
0 to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Rybakov, Dr.Med.Sc.
Phone
+7 499 199 86 43
Email
erybakov@gmail.com
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
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