Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial
Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. This multicentre, randomized, open-label, non-inferiority cl...
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| Veröffentlicht in: | British journal of surgery 2022-02, Vol.109 (3), p.267-273 |
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| creator | van Braak, Willemieke G Ponten, Jeroen E H Loozen, Charlotte S Schots, Judith P M van Geloven, Anna A W Donkervoort, Sandra C Nieuwenhuijzen, Grard A P Besselink, Marc G van Heek, Tjarda N T de Reuver, Philip R Vlaminckx, Bart Kelder, Johannes C Knibbe, Catherijne A J van Santvoort, Hjalmar C Boerma, Djamila |
| description | Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.
This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
Omitting antibiotic prophylaxis is not recommended. |
| doi_str_mv | 10.1093/bjs/znab441 |
| format | Article |
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This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
Omitting antibiotic prophylaxis is not recommended.</description><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1093/bjs/znab441</identifier><identifier>PMID: 35020797</identifier><language>eng</language><publisher>England</publisher><subject>Antibiotic Prophylaxis ; Bacterial Infections - prevention & control ; Bile - microbiology ; Cefazolin - therapeutic use ; Cholecystectomy, Laparoscopic - adverse effects ; Cholecystitis, Acute - surgery ; Conversion to Open Surgery ; Equivalence Trials as Topic ; Female ; Humans ; Length of Stay ; Male ; Middle Aged ; Risk Factors ; Surgical Wound Infection - prevention & control</subject><ispartof>British journal of surgery, 2022-02, Vol.109 (3), p.267-273</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c290t-968e86ad7410cff47ad4df6f4d117cc8136fb835088a7c7dfe608afb349ace723</citedby><orcidid>0000-0001-9893-4415 ; 0000-0002-5837-5513</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35020797$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Braak, Willemieke G</creatorcontrib><creatorcontrib>Ponten, Jeroen E H</creatorcontrib><creatorcontrib>Loozen, Charlotte S</creatorcontrib><creatorcontrib>Schots, Judith P M</creatorcontrib><creatorcontrib>van Geloven, Anna A W</creatorcontrib><creatorcontrib>Donkervoort, Sandra C</creatorcontrib><creatorcontrib>Nieuwenhuijzen, Grard A P</creatorcontrib><creatorcontrib>Besselink, Marc G</creatorcontrib><creatorcontrib>van Heek, Tjarda N T</creatorcontrib><creatorcontrib>de Reuver, Philip R</creatorcontrib><creatorcontrib>Vlaminckx, Bart</creatorcontrib><creatorcontrib>Kelder, Johannes C</creatorcontrib><creatorcontrib>Knibbe, Catherijne A J</creatorcontrib><creatorcontrib>van Santvoort, Hjalmar C</creatorcontrib><creatorcontrib>Boerma, Djamila</creatorcontrib><title>Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.
This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
Omitting antibiotic prophylaxis is not recommended.</description><subject>Antibiotic Prophylaxis</subject><subject>Bacterial Infections - prevention & control</subject><subject>Bile - microbiology</subject><subject>Cefazolin - therapeutic use</subject><subject>Cholecystectomy, Laparoscopic - adverse effects</subject><subject>Cholecystitis, Acute - surgery</subject><subject>Conversion to Open Surgery</subject><subject>Equivalence Trials as Topic</subject><subject>Female</subject><subject>Humans</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Risk Factors</subject><subject>Surgical Wound Infection - prevention & control</subject><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kM9LwzAAhYMgbk5P3iVHL3VJmzaptzE2HQwV3M4lzQ-WkSYzScHur7fgPL3L9x58D4AHjJ4xqot5e4zzs-MtIfgKTHFRlVmOKzYBtzEeEcIFKvMbMClKlCNa0ykIC5dMa3wyAp6CPx0Gy39MhNoHyEWfFBQHb5UYYlIi-W54gZ-rxft-9wU3G9j1diwql4KCgTvpO3NWEjrvMuO0CsYHkwYorHFGcAtTMNzegWvNbVT3l5yB_Xq1W75l24_XzXKxzUReo5TVFVOs4pISjITWhHJJpK40kRhTIdgop1s2mjDGqaBSqwoxrtuC1Fwomhcz8PS3O3p99yqmpjNRKGu5U76PTV7huiRlSesRfbygfdsp2ZyC6XgYmv-fil8a3msx</recordid><startdate>20220224</startdate><enddate>20220224</enddate><creator>van Braak, Willemieke G</creator><creator>Ponten, Jeroen E H</creator><creator>Loozen, Charlotte S</creator><creator>Schots, Judith P M</creator><creator>van Geloven, Anna A W</creator><creator>Donkervoort, Sandra C</creator><creator>Nieuwenhuijzen, Grard A P</creator><creator>Besselink, Marc G</creator><creator>van Heek, Tjarda N T</creator><creator>de Reuver, Philip R</creator><creator>Vlaminckx, Bart</creator><creator>Kelder, Johannes C</creator><creator>Knibbe, Catherijne A J</creator><creator>van Santvoort, Hjalmar C</creator><creator>Boerma, Djamila</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9893-4415</orcidid><orcidid>https://orcid.org/0000-0002-5837-5513</orcidid></search><sort><creationdate>20220224</creationdate><title>Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial</title><author>van Braak, Willemieke G ; Ponten, Jeroen E H ; Loozen, Charlotte S ; Schots, Judith P M ; van Geloven, Anna A W ; Donkervoort, Sandra C ; Nieuwenhuijzen, Grard A P ; Besselink, Marc G ; van Heek, Tjarda N T ; de Reuver, Philip R ; Vlaminckx, Bart ; Kelder, Johannes C ; Knibbe, Catherijne A J ; van Santvoort, Hjalmar C ; Boerma, Djamila</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c290t-968e86ad7410cff47ad4df6f4d117cc8136fb835088a7c7dfe608afb349ace723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Antibiotic Prophylaxis</topic><topic>Bacterial Infections - prevention & control</topic><topic>Bile - microbiology</topic><topic>Cefazolin - therapeutic use</topic><topic>Cholecystectomy, Laparoscopic - adverse effects</topic><topic>Cholecystitis, Acute - surgery</topic><topic>Conversion to Open Surgery</topic><topic>Equivalence Trials as Topic</topic><topic>Female</topic><topic>Humans</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Risk Factors</topic><topic>Surgical Wound Infection - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Braak, Willemieke G</creatorcontrib><creatorcontrib>Ponten, Jeroen E H</creatorcontrib><creatorcontrib>Loozen, Charlotte S</creatorcontrib><creatorcontrib>Schots, Judith P M</creatorcontrib><creatorcontrib>van Geloven, Anna A W</creatorcontrib><creatorcontrib>Donkervoort, Sandra C</creatorcontrib><creatorcontrib>Nieuwenhuijzen, Grard A P</creatorcontrib><creatorcontrib>Besselink, Marc G</creatorcontrib><creatorcontrib>van Heek, Tjarda N T</creatorcontrib><creatorcontrib>de Reuver, Philip R</creatorcontrib><creatorcontrib>Vlaminckx, Bart</creatorcontrib><creatorcontrib>Kelder, Johannes C</creatorcontrib><creatorcontrib>Knibbe, Catherijne A J</creatorcontrib><creatorcontrib>van Santvoort, Hjalmar C</creatorcontrib><creatorcontrib>Boerma, Djamila</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Braak, Willemieke G</au><au>Ponten, Jeroen E H</au><au>Loozen, Charlotte S</au><au>Schots, Judith P M</au><au>van Geloven, Anna A W</au><au>Donkervoort, Sandra C</au><au>Nieuwenhuijzen, Grard A P</au><au>Besselink, Marc G</au><au>van Heek, Tjarda N T</au><au>de Reuver, Philip R</au><au>Vlaminckx, Bart</au><au>Kelder, Johannes C</au><au>Knibbe, Catherijne A J</au><au>van Santvoort, Hjalmar C</au><au>Boerma, Djamila</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2022-02-24</date><risdate>2022</risdate><volume>109</volume><issue>3</issue><spage>267</spage><epage>273</epage><pages>267-273</pages><eissn>1365-2168</eissn><abstract>Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use.
This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay.
Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay.
Omitting antibiotic prophylaxis is not recommended.</abstract><cop>England</cop><pmid>35020797</pmid><doi>10.1093/bjs/znab441</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-9893-4415</orcidid><orcidid>https://orcid.org/0000-0002-5837-5513</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | EISSN: 1365-2168 |
| ispartof | British journal of surgery, 2022-02, Vol.109 (3), p.267-273 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE |
| subjects | Antibiotic Prophylaxis Bacterial Infections - prevention & control Bile - microbiology Cefazolin - therapeutic use Cholecystectomy, Laparoscopic - adverse effects Cholecystitis, Acute - surgery Conversion to Open Surgery Equivalence Trials as Topic Female Humans Length of Stay Male Middle Aged Risk Factors Surgical Wound Infection - prevention & control |
| title | Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial |
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