Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
536

Summary

Conditions
  • Surgery- Complications
  • Wounds and Injuries
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

International, multicentre, pragmatic, parallel-group, randomised controlled trial. Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colonic surgery that involves colonic resection. The antibiotic prophy...

International, multicentre, pragmatic, parallel-group, randomised controlled trial. Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colonic 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, plus mechanical bowel preparation with Sodium picosulfate, light magnesium oxide, and anhydrous citric acid (10 mg - 3.5 g - 10.97 g per dose/ 2 doses the day before surgery) + An intravenous antibiotics pattern of cefuroxime 1,5 g and metronidazole 1 g at anesthetic induction. Control group: Patients undergoing elective colonic 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) + An intravenous antibiotic pattern of cefuroxime 1,5 g and metronidazole 1 gr at anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time prolongs for more than three hours or if there is an intraoperative bleeding over 1000cc. There will not be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Tracking Information

NCT #
NCT04161599
Collaborators
Not Provided
Investigators
Study Chair: Eloy Espín-Basany, MD PhD Hospital Universitario Valle de Hebron, Barcelona