Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Study Overview
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Brief Summary
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The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

Detailed Description
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The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Official Title
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Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: cefmetazole
* Drug: kanamycin/metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection Exclusion Criteria: ECOG Performance Status >=2 Age<20 Any organ dysfunction Ileus Preoperative infectious disease Antibiotic administration before surgery Steroid administration before surgery Neo-adjuvant radiation and/or chemo therapy Severe diabetes mellitus Pregnancy/lactational woman Severe allergy

Ages Eligible for Study
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Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV<br>Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery | Drug: cefmetazole<br>* Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery<br>|
| Active Comparator: Oral/IV<br>2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery | Drug: kanamycin/metronidazole<br>* 2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and classification of surgical site infection (SSI) |  | Within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of colitis, other infectious diseases and other postoperative complications. |  | Within the first 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy