NCT01220661

Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery

Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses. It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Detailed description

In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses. One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%) It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
DRUG	Cefotetan	preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-10-14
• Last updated: 2011-12-13

Locations

1 site across 1 country: South Korea