NCT02505581

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-04-01
• Completion: 2018-11-10
• First posted: 2015-07-22
• Last updated: 2020-01-14

Locations

3 sites across 1 country: Spain