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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000000776 |
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The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV | Active Comparator | Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery |
|
| Oral/IV | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefmetazole | Drug | Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and classification of surgical site infection (SSI) | Within the first 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of colitis, other infectious diseases and other postoperative complications. | Within the first 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Hata, MD | National Hospital Organization Kyoto Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto Univercity Hospital | Kyoto | Kyoto | 606-8507 | Japan | ||
| National Hospital Organization, Kyoto Medical Center |
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| Label | URL |
|---|---|
| UMIN Clinical Trial Registry: Unique trial number UMIN000000776 | View source |
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| kanamycin/metronidazole | Drug | 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 |
|
| Kyoto |
| Kyoto |
| 612-8555 |
| Japan |
| Kyoto Katsura Hospital | Kyoto | Kyoto | 6158256 | Japan |
| Tenriyorozu Hospital | Tenri | Nara | 6328552 | Japan |
| Kitano Hospital | Osaka | Osaka | 5308480 | Japan |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D015311 | Cefmetazole |
| D007612 | Kanamycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D002513 | Cephamycins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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