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

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.

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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

Conditions

• Surgical Wound Infection

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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Eloy Espin Basany, MD PhD · Hospital Universitari Vall d'Hebron Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-04-30

Completion

2018-11-10

Countries

• Spain

Study Locations