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

Last updated: January 12, 2020
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Completed

Phase

4

Condition

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT02505581
2014-002345-21
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 informedconsent.

Exclusion

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 priorto surgery.

  • Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease andindeterminate colitis)

  • Patients presenting allergy to the drugs under study.

  • Patients that will not strictly follow the assigned prophylaxis regimen

  • Patients undergoing urgent surgery (<24h)

Study Design

Total Participants: 536
Study Start date:
May 01, 2015
Estimated Completion Date:
November 10, 2018

Connect with a study center

  • Hospital de Bellvitge

    Hospitalet de Llobregat, Barcelona
    Spain

    Site Not Available

  • Hospital General Universitario Vall d´Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

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