Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

Study Overview
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Brief Summary
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Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. + Control group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Official Title
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Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Drug: Extra dosage - cefuroxime (750mg) I.V
* Procedure: Colorectal Surgery
* Drug: Ciprofloxacin 750 mg oral
* Drug: Metronidazole 250 mg oral
* Drug: Cefuroxime 1.5 g Intravenous
* Drug: Metronidazole 1 g Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting colonic pathology The surgery is not contraindicated Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..) Indication of segmentary resection or total colectomy Patients who agree to participate voluntarily in the study and signed an informed consent. Exclusion Criteria: Patients who refuse to participate in the study. Patients undergoing mechanical colon preparation the day before surgery. Patients with rectal cancer Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis). Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery. Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis) Patients presenting allergy to the drugs under study. Patients that will not strictly follow the assigned prophylaxis regimen Patients undergoing urgent surgery (<24h)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral + Parenteral prophylaxis<br> | Drug: Extra dosage - cefuroxime (750mg) I.V<br>* In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc<br>Procedure: Colorectal Surgery<br>* Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)<br>Drug: Ciprofloxacin 750 mg oral<br>* An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.<br>Drug: Metronidazole 250 mg oral<br>* An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.<br>Drug: Cefuroxime 1.5 g Intravenous<br>* An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.<br>Drug: Metronidazole 1 g Intravenous<br>* An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.<br>|
| Active Comparator: Only Parenteral prophylaxis<br> | Drug: Extra dosage - cefuroxime (750mg) I.V<br>* In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc<br>Procedure: Colorectal Surgery<br>* Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)<br>Drug: Cefuroxime 1.5 g Intravenous<br>* An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.<br>Drug: Metronidazole 1 g Intravenous<br>* An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection | Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital stay since colorectal surgery is done | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Direct Adverse Drug Reactions | Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable | 24 hours since the drug is taken | 
| Occlusive problems | Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications... •This morbidity problems are reported independently as a YES/NO variable | 30 days from surgery | 
| Iatrogenic problems | Damage to structures such as ureters, bowel loops artery / iliac vein .... •This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Impaired healing | This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Bleeding problems | Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Cardiac complications | acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this items | 30 days after surgery | 
| Nephro-urinary complications | Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ... This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Respiratory complications | Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ... This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Vascular Complications | Deep venous thrombosis, phlebitis, thrombophlebitis, ... This is a Clinical measure supported by more specific test if necessary . This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Gastrointestinal complications | Liver failure, gastrointestinal bleeding, severe malnutrition, ... This is a Clinical measure supported by blood test and further test if necessary This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Neurological complications | Disorientation, cerebral vascular accident, ... This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation. | 30 days after surgery | 
| Local infection | Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 
| Local complications | Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis