Status:
COMPLETED
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
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 surgica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01220661
Start Date
October 1 2010
End Date
December 1 2011
Last Update
December 13 2011
Active Locations (1)
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1
National Cancer Center Hospital
Goyang-si, Gyeonggi-do, South Korea, 410-769