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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ji Won Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01220661
First received: October 12, 2010
Last updated: December 11, 2011
Last verified: December 2011

October 12, 2010
December 11, 2011
October 2010
December 2011   (final data collection date for primary outcome measure)
Surgical site infection [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: Yes ]
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
Same as current
Complete list of historical versions of study NCT01220661 on ClinicalTrials.gov Archive Site
Overall infection [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: Yes ]
Overall infection including surgical site infection, pneumonia, urinary tract infection etc.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
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.

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.

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
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Surgery
Drug: Cefotetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Other Name: Yamatetan
Experimental: One dose
One dose prophylactic antibiotic
Intervention: Drug: Cefotetan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
  • Patients should sign a written informed consent
  • Age between 18-80 years
  • Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
  • Adequate kidney function Creatinine ≤ 1.5 mg/dl
  • No remarkable evidence of heart dysfunction and lung dysfunction

Exclusion Criteria:

  • Patients undergo emergency surgery with multiple symptoms
  • Open colorectal surgery for cancer or conversion to an open procedure
  • Patients who undergo only ostomy surgery
  • Palliative surgery
  • Surgery combined with other organs
  • Patients on treatment with recurred cancer
  • Patients who have active bacterial infection and required parenteral antibiotics
  • Patients have an allergy to Cefoxitin
  • Other organ cancer history(except who had radical excision for skin cancer)
  • Presence of other serious disease
  • Mentally ill patients
  • Legally unable to participate in clinical trial
  • Lactating or pregnant women
  • Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
  • Not eligible to participate for other reasons by doctor's decision
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01220661
NCCCTS-10-485
No
Ji Won Park, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Jae Hwan Oh Center for Colorectal Cancer, National Cancer Center Korea
National Cancer Center, Korea
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP