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

National Cancer Center (NCC)

Status and phase

Completed

Phase 2

Conditions

Colorectal Surgery

Treatments

Drug: Cefotetan

Study type

Interventional

Funder types

Other

Identifiers

NCT01220661

NCCCTS-10-485

Details and patient eligibility

About

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.

Full 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%)

The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Enrollment

312 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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