Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
NCT ID: NCT01220661
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
312 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One dose
One dose prophylactic antibiotic
Cefotetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Interventions
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Cefotetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Ji Won Park
M.D.
Principal Investigators
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Jae Hwan Oh
Role: PRINCIPAL_INVESTIGATOR
Center for Colorectal Cancer, National Cancer Center Korea
Locations
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National Cancer Center Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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NCCCTS-10-485
Identifier Type: -
Identifier Source: org_study_id