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

Phase 2

Completed

• Conditions: Colorectal Surgery
• Interventions: Drug: Cefotetan

• Registration Number: NCT01220661
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-11
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One dose	Cefotetan	One dose prophylactic antibiotic

Primary Outcome Measures

Name	Time	Method
Surgical site infection	Three weeks after surgery	any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)

Secondary Outcome Measures

Name	Time	Method
Overall infection	Three weeks after surgery	Overall infection including surgical site infection, pneumonia, urinary tract infection etc.

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of