Clinical trial NCT01220661: Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Official title: Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Surgery
Keywords: Colorectal Surgery
Surgical Wound Infection
Laparoscopy
Anti-Bacterial Agents
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2010-10-14
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Surgical site infection
timeFrame: Three weeks after surgery
Secondary outcomes:
measure: Overall infection
timeFrame: Three weeks after surgery
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Hospital
state: Gyeonggi-do
Study officials:
affiliation: Center for Colorectal Cancer, National Cancer Center Korea
name: Jae Hwan Oh
role: PRINCIPAL_INVESTIGATOR
References: