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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery
• Intervention / Treatment: Drug: Cefotetan

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.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One dose; One dose prophylactic antibiotic	Drug: Cefotetan; preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision); Other Names: Yamatetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)	Three weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall infection	Overall infection including surgical site infection, pneumonia, urinary tract infection etc.	Three weeks after surgery

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Jae Hwan Oh, Center for Colorectal Cancer, National Cancer Center Korea

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 11, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Laparoscopy; Colorectal Surgery; Anti-Bacterial Agents; Surgical Wound Infection
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefotetan
• Other Study ID Numbers: NCCCTS-10-485