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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
  Purpose

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.


Condition Intervention Phase
Colorectal Surgery
 Drug: Cefotetan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Overall infection [ Time Frame: Three weeks after surgery ] [ Designated as safety issue: Yes ]
    Overall infection including surgical site infection, pneumonia, urinary tract infection etc.


Enrollment: 312
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One dose
One dose prophylactic antibiotic
 Drug: Cefotetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
Other Name: Yamatetan

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220661

Locations
Korea, Republic of
National Cancer Center Hospital
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jae Hwan Oh Center for Colorectal Cancer, National Cancer Center Korea
  More Information

No publications provided

Responsible Party: Ji Won Park, M.D., National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01220661     History of Changes
Other Study ID Numbers: NCCCTS-10-485
Study First Received: October 12, 2010
Last Updated: December 11, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Colorectal Surgery
Surgical Wound Infection
Laparoscopy
Anti-Bacterial Agents

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefotetan
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013