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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220661
• Other study ID #: NCCCTS-10-485
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: December 11, 2011
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• Cefotetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Hospital	Goyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)	Three weeks after surgery	Yes
Secondary	Overall infection	Overall infection including surgical site infection, pneumonia, urinary tract infection etc.	Three weeks after surgery	Yes