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

Phase 2
18 Years
80 Years
Not Enrolling
Colorectal Surgery

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Trial Information

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.

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.

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

- Not eligible to participate for other reasons by doctor's decision

Type of Study:


Study Design:

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

Outcome Measure:

Surgical site infection

Outcome Description:

any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)

Outcome Time Frame:

Three weeks after surgery

Safety Issue:


Principal Investigator

Jae Hwan Oh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Colorectal Cancer, National Cancer Center Korea


Korea: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

December 2011

Related Keywords:

  • Colorectal Surgery
  • Colorectal Surgery
  • Surgical Wound Infection
  • Laparoscopy
  • Anti-Bacterial Agents