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

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ClinicalTrials.gov Identifier: NCT02505581
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Surgical Wound Infection 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 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral + Parenteral prophylaxis 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.
Active Comparator: Only Parenteral prophylaxis 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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


  3. 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


  4. 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


  5. 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

  6. Bleeding problems [ Time Frame: 30 days after surgery ]

    Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....

    •This morbidity problems are reported independently as a YES/NO variable


  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505581


Locations
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Spain
Hospital de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Vall d´Hebron
Barcelona, Spain, 08035
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain, 17007
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Study Chair: Eloy Espin Basany, MD PhD Hospital Universitari Vall d'Hebron Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02505581    
Other Study ID Numbers: 2014-002345-21
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Postoperative Wound Infection
Surgical Wound Infection
Colorectal Surgery Infection Prophylaxis
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Wound Infection
Surgical Wound Infection
Surgical Wound
Disease Attributes
Pathologic Processes
Wounds and Injuries
Postoperative Complications
Metronidazole
Ciprofloxacin
Cefuroxime
 Cefuroxime axetil
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors