Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Surgical site infection
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
Three weeks after surgery
Yes
Jae Hwan Oh
Principal Investigator
Center for Colorectal Cancer, National Cancer Center Korea
Korea: Institutional Review Board
NCCCTS-10-485
NCT01220661
October 2010
December 2011
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