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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Drug: Cefotetan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One dose<br>One dose prophylactic antibiotic | Drug: Cefotetan<br>* preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)<br>* Other names: Yamatetan;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery, Surgical Wound Infection, Laparoscopy, Anti-Bacterial Agents