Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial
Purposes This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection. Method We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patient...
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| Veröffentlicht in: | Surgery today (Tokyo, Japan) Japan), 2019-10, Vol.49 (10), p.859-869 |
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| container_title | Surgery today (Tokyo, Japan) |
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| creator | Takayama, Tadatoshi Aramaki, Osamu Shibata, Taro Oka, Masaaki Itamoto, Toshiyuki Shimada, Mitsuo Isaji, Shuji Kanematsu, Takashi Kubo, Shoji Kusunoki, Masato Mochizuki, Hidetaka Sumiyama, Yoshinobu |
| description | Purposes
This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.
Method
We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.
Results
Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, – 0.30; 90% CI – 4.80 to 4.19% [95% CI – 5.66% to 5.05%]; one-sided
P
= 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%],
P
˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%],
P
˂ 0.001 for non-inferiority) were comparable.
Conclusion
To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage. |
| doi_str_mv | 10.1007/s00595-019-01813-w |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2216771749</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2216771749</sourcerecordid><originalsourceid>FETCH-LOGICAL-c437t-d3836695ea8030c934cc8c01a85c9a48b5d6de9c3af7d7eff7a727738d6f3d573</originalsourceid><addsrcrecordid>eNp9kE1PxCAQhonRuOvqH_BgOHpBobSleNts_Eo28aJnwgJVNi2s0OrWXy9rV48eyDAz77wwDwDnBF8RjNl1xLjgBcKEp1MRij4PwJTktERZyg7BFPOcIJJxMgEnMa4xzvIK42MwoQRTnJXlFGznrrOtVcGvrGzgJvjN29DIrY2w9gESqOUAP0yIfYR0l0RoHWxsKkElnUoh9uHVhOEGShik0761X0ZD5V0XfNOkq_MOWVebYH2w3QC7kJ46BUe1bKI528cZeLm7fV48oOXT_eNivkQqp6xDmla0LHlhZJW-rDjNlaoUJrIqFJd5tSp0qQ1XVNZMM1PXTLKMMVrpsqa6YHQGLkfftNp7b2InWhuVaRrpjO-jyDJSMkZYzpM0G6WJRozB1GITbCvDIAgWO-JiJC4ScfFDXHymoYu9f79qjf4b-UWcBHQUxNRyiZRY-z64tPN_tt--E46k</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2216771749</pqid></control><display><type>article</type><title>Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Takayama, Tadatoshi ; Aramaki, Osamu ; Shibata, Taro ; Oka, Masaaki ; Itamoto, Toshiyuki ; Shimada, Mitsuo ; Isaji, Shuji ; Kanematsu, Takashi ; Kubo, Shoji ; Kusunoki, Masato ; Mochizuki, Hidetaka ; Sumiyama, Yoshinobu</creator><creatorcontrib>Takayama, Tadatoshi ; Aramaki, Osamu ; Shibata, Taro ; Oka, Masaaki ; Itamoto, Toshiyuki ; Shimada, Mitsuo ; Isaji, Shuji ; Kanematsu, Takashi ; Kubo, Shoji ; Kusunoki, Masato ; Mochizuki, Hidetaka ; Sumiyama, Yoshinobu</creatorcontrib><description>Purposes
This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.
Method
We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.
Results
Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, – 0.30; 90% CI – 4.80 to 4.19% [95% CI – 5.66% to 5.05%]; one-sided
P
= 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%],
P
˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%],
P
˂ 0.001 for non-inferiority) were comparable.
Conclusion
To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.</description><identifier>ISSN: 0941-1291</identifier><identifier>EISSN: 1436-2813</identifier><identifier>DOI: 10.1007/s00595-019-01813-w</identifier><identifier>PMID: 31030266</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Aged ; Anti-Bacterial Agents - administration & dosage ; Antibiotic Prophylaxis ; Carcinoma, Hepatocellular - surgery ; Cephalosporins - administration & dosage ; Female ; Hepatectomy ; Humans ; Japan ; Liver Neoplasms - surgery ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Article ; Surgery ; Surgical Oncology ; Surgical Wound Infection - epidemiology ; Surgical Wound Infection - prevention & control ; Time Factors</subject><ispartof>Surgery today (Tokyo, Japan), 2019-10, Vol.49 (10), p.859-869</ispartof><rights>Springer Nature Singapore Pte Ltd. 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c437t-d3836695ea8030c934cc8c01a85c9a48b5d6de9c3af7d7eff7a727738d6f3d573</citedby><cites>FETCH-LOGICAL-c437t-d3836695ea8030c934cc8c01a85c9a48b5d6de9c3af7d7eff7a727738d6f3d573</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00595-019-01813-w$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00595-019-01813-w$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31030266$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Takayama, Tadatoshi</creatorcontrib><creatorcontrib>Aramaki, Osamu</creatorcontrib><creatorcontrib>Shibata, Taro</creatorcontrib><creatorcontrib>Oka, Masaaki</creatorcontrib><creatorcontrib>Itamoto, Toshiyuki</creatorcontrib><creatorcontrib>Shimada, Mitsuo</creatorcontrib><creatorcontrib>Isaji, Shuji</creatorcontrib><creatorcontrib>Kanematsu, Takashi</creatorcontrib><creatorcontrib>Kubo, Shoji</creatorcontrib><creatorcontrib>Kusunoki, Masato</creatorcontrib><creatorcontrib>Mochizuki, Hidetaka</creatorcontrib><creatorcontrib>Sumiyama, Yoshinobu</creatorcontrib><title>Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial</title><title>Surgery today (Tokyo, Japan)</title><addtitle>Surg Today</addtitle><addtitle>Surg Today</addtitle><description>Purposes
This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.
Method
We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.
Results
Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, – 0.30; 90% CI – 4.80 to 4.19% [95% CI – 5.66% to 5.05%]; one-sided
P
= 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%],
P
˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%],
P
˂ 0.001 for non-inferiority) were comparable.
Conclusion
To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.</description><subject>Aged</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Antibiotic Prophylaxis</subject><subject>Carcinoma, Hepatocellular - surgery</subject><subject>Cephalosporins - administration & dosage</subject><subject>Female</subject><subject>Hepatectomy</subject><subject>Humans</subject><subject>Japan</subject><subject>Liver Neoplasms - surgery</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Surgical Wound Infection - epidemiology</subject><subject>Surgical Wound Infection - prevention & control</subject><subject>Time Factors</subject><issn>0941-1291</issn><issn>1436-2813</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1PxCAQhonRuOvqH_BgOHpBobSleNts_Eo28aJnwgJVNi2s0OrWXy9rV48eyDAz77wwDwDnBF8RjNl1xLjgBcKEp1MRij4PwJTktERZyg7BFPOcIJJxMgEnMa4xzvIK42MwoQRTnJXlFGznrrOtVcGvrGzgJvjN29DIrY2w9gESqOUAP0yIfYR0l0RoHWxsKkElnUoh9uHVhOEGShik0761X0ZD5V0XfNOkq_MOWVebYH2w3QC7kJ46BUe1bKI528cZeLm7fV48oOXT_eNivkQqp6xDmla0LHlhZJW-rDjNlaoUJrIqFJd5tSp0qQ1XVNZMM1PXTLKMMVrpsqa6YHQGLkfftNp7b2InWhuVaRrpjO-jyDJSMkZYzpM0G6WJRozB1GITbCvDIAgWO-JiJC4ScfFDXHymoYu9f79qjf4b-UWcBHQUxNRyiZRY-z64tPN_tt--E46k</recordid><startdate>20191001</startdate><enddate>20191001</enddate><creator>Takayama, Tadatoshi</creator><creator>Aramaki, Osamu</creator><creator>Shibata, Taro</creator><creator>Oka, Masaaki</creator><creator>Itamoto, Toshiyuki</creator><creator>Shimada, Mitsuo</creator><creator>Isaji, Shuji</creator><creator>Kanematsu, Takashi</creator><creator>Kubo, Shoji</creator><creator>Kusunoki, Masato</creator><creator>Mochizuki, Hidetaka</creator><creator>Sumiyama, Yoshinobu</creator><general>Springer Singapore</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20191001</creationdate><title>Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial</title><author>Takayama, Tadatoshi ; Aramaki, Osamu ; Shibata, Taro ; Oka, Masaaki ; Itamoto, Toshiyuki ; Shimada, Mitsuo ; Isaji, Shuji ; Kanematsu, Takashi ; Kubo, Shoji ; Kusunoki, Masato ; Mochizuki, Hidetaka ; Sumiyama, Yoshinobu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c437t-d3836695ea8030c934cc8c01a85c9a48b5d6de9c3af7d7eff7a727738d6f3d573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Antibiotic Prophylaxis</topic><topic>Carcinoma, Hepatocellular - surgery</topic><topic>Cephalosporins - administration & dosage</topic><topic>Female</topic><topic>Hepatectomy</topic><topic>Humans</topic><topic>Japan</topic><topic>Liver Neoplasms - surgery</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Surgical Wound Infection - epidemiology</topic><topic>Surgical Wound Infection - prevention & control</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Takayama, Tadatoshi</creatorcontrib><creatorcontrib>Aramaki, Osamu</creatorcontrib><creatorcontrib>Shibata, Taro</creatorcontrib><creatorcontrib>Oka, Masaaki</creatorcontrib><creatorcontrib>Itamoto, Toshiyuki</creatorcontrib><creatorcontrib>Shimada, Mitsuo</creatorcontrib><creatorcontrib>Isaji, Shuji</creatorcontrib><creatorcontrib>Kanematsu, Takashi</creatorcontrib><creatorcontrib>Kubo, Shoji</creatorcontrib><creatorcontrib>Kusunoki, Masato</creatorcontrib><creatorcontrib>Mochizuki, Hidetaka</creatorcontrib><creatorcontrib>Sumiyama, Yoshinobu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Surgery today (Tokyo, Japan)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Takayama, Tadatoshi</au><au>Aramaki, Osamu</au><au>Shibata, Taro</au><au>Oka, Masaaki</au><au>Itamoto, Toshiyuki</au><au>Shimada, Mitsuo</au><au>Isaji, Shuji</au><au>Kanematsu, Takashi</au><au>Kubo, Shoji</au><au>Kusunoki, Masato</au><au>Mochizuki, Hidetaka</au><au>Sumiyama, Yoshinobu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial</atitle><jtitle>Surgery today (Tokyo, Japan)</jtitle><stitle>Surg Today</stitle><addtitle>Surg Today</addtitle><date>2019-10-01</date><risdate>2019</risdate><volume>49</volume><issue>10</issue><spage>859</spage><epage>869</epage><pages>859-869</pages><issn>0941-1291</issn><eissn>1436-2813</eissn><abstract>Purposes
This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.
Method
We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.
Results
Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, – 0.30; 90% CI – 4.80 to 4.19% [95% CI – 5.66% to 5.05%]; one-sided
P
= 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%],
P
˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%],
P
˂ 0.001 for non-inferiority) were comparable.
Conclusion
To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><pmid>31030266</pmid><doi>10.1007/s00595-019-01813-w</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0941-1291 |
| ispartof | Surgery today (Tokyo, Japan), 2019-10, Vol.49 (10), p.859-869 |
| issn | 0941-1291 1436-2813 |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Aged Anti-Bacterial Agents - administration & dosage Antibiotic Prophylaxis Carcinoma, Hepatocellular - surgery Cephalosporins - administration & dosage Female Hepatectomy Humans Japan Liver Neoplasms - surgery Male Medicine Medicine & Public Health Middle Aged Original Article Surgery Surgical Oncology Surgical Wound Infection - epidemiology Surgical Wound Infection - prevention & control Time Factors |
| title | Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial |
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