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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
536
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
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Vall d´Hebron
Barcelona, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain
Wound infection
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
Time frame: 30 days
Hospital stay
Hospital stay since colorectal surgery is done
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days after surgery
Bleeding problems
Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 30 days after surgery
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