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

Information source: National Cancer Center, Korea
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Surgery

Intervention: Cefotetan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Center, Korea

Official(s) and/or principal investigator(s):
Jae Hwan Oh, Principal Investigator, Affiliation: Center for Colorectal Cancer, National Cancer Center Korea

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Surgical site infection

Secondary outcome: Overall 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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

National Cancer Center Hospital, Goyang, Gyeonggi-do 410-769, Korea, Republic of
Additional Information

Starting date: October 2010
Last updated: December 11, 2011

Page last updated: August 20, 2015

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