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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Oral antibiotic
* Drug: Intravenous antibiotic
* Drug: Mechanical Bowel Preparation


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral with Intravenous<br>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<br>* 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<br>* Other names: Erythromycin;Drug: Intravenous antibiotic<br>* Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery<br>* Other names: Cefoperazone;Drug: Mechanical Bowel Preparation<br>* Beginning of MBP at 4 p.m. in a day before surgery<br>* Other names: polyethylene glycol;|
| Active Comparator: Intravenous<br>Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery | Drug: Intravenous antibiotic<br>* Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery<br>* Other names: Cefoperazone;Drug: Mechanical Bowel Preparation<br>* Beginning of MBP at 4 p.m. in a day before surgery<br>* Other names: polyethylene glycol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Site Infection |  | 0 to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Site Infection, Rectal Cancer Surgery, Oral Antibiotic, Antibiotic Prophylaxis