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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ji Won Park, National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT01220661

First received: October 12, 2010

Last updated: December 11, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2010

Last Updated Date

December 11, 2011

Start Date ^ICMJE

October 2010

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Surgical site infection [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01220661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall infection [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: Yes ]

Overall infection including surgical site infection, pneumonia, urinary tract infection etc.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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%)

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Surgery

Intervention ^ICMJE

Drug: Cefotetan

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

Other Name: Yamatetan

Study Arm (s)

Experimental: One dose

One dose prophylactic antibiotic

Intervention: Drug: Cefotetan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

312

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01220661

Other Study ID Numbers ^ICMJE

NCCCTS-10-485

Has Data Monitoring Committee

Responsible Party

Ji Won Park, National Cancer Center, Korea

Study Sponsor ^ICMJE

National Cancer Center, Korea

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jae Hwan Oh

Center for Colorectal Cancer, National Cancer Center Korea

Information Provided By

National Cancer Center, Korea

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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