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

Overview

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.

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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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2017

Interventions

  • Drug: Extra dosage – cefuroxime (750mg) I.V
    • 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
  • Procedure: Colorectal Surgery
    • Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
  • Drug: Ciprofloxacin 750 mg oral
    • An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
  • Drug: Metronidazole 250 mg oral
    • An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
  • Drug: Cefuroxime 1.5 g Intravenous
    • An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
  • Drug: Metronidazole 1 g Intravenous
    • An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.

Arms, Groups and Cohorts

  • Experimental: Oral + Parenteral prophylaxis
  • Active Comparator: Only Parenteral prophylaxis

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Hospital stay
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
    • Hospital stay since colorectal surgery is done
  • Direct Adverse Drug Reactions
    • Time Frame: 24 hours since the drug is taken
    • Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable
  • Occlusive problems
    • Time Frame: 30 days from surgery
    • 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
  • Iatrogenic problems
    • Time Frame: 30 days after surgery
    • Damage to structures such as ureters, bowel loops artery / iliac vein …. •This morbidity problems are reported independently as a YES/NO variable
  • Impaired healing
    • Time Frame: 30 days after surgery
    • This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
  • Bleeding problems
    • Time Frame: 30 days after surgery
    • Hemoperitoneum, abdominal hematoma,anastomotic bleeding …. •This morbidity problems are reported independently as a YES/NO variable
  • Cardiac complications
    • Time Frame: 30 days after surgery
    • 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
  • Nephro-urinary complications
    • Time Frame: 30 days after surgery
    • 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
  • Respiratory complications
    • Time Frame: 30 days after surgery
    • 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
  • Vascular Complications
    • Time Frame: 30 days after surgery
    • 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
  • Gastrointestinal complications
    • Time Frame: 30 days after surgery
    • 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
  • Neurological complications
    • Time Frame: 30 days after surgery
    • 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.
  • Local infection
    • Time Frame: 30 days after surgery
    • 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
  • Local complications
    • Time Frame: 30 days after surgery
    • Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eloy Espin Basany, MD PhD, Study Chair, Hospital Universitari Vall d’Hebron Research Institute

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