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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefotetan

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