Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial
BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiot...
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| creator | Hall, Nigel J Eaton, Simon Abbo, Olivier Arnaud, Alexis P Beaudin, Marianne Brindle, Mary Bütter, Andreana Davies, Dafydd Jancelewicz, Tim Johnson, Kathy Keijzer, Richard Lapidus-Krol, Eveline Offringa, Martin Piché, Nelson Rintala, Risto Skarsgard, Erik Svensson, Jan F Ungar, Wendy J Wester, Tomas Willan, Andrew R Zani, Augusto St Peter, Shawn D Pierro, Agostino |
| description | BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.MethodsMulticentre, international, randomised controlled trial with a non-inferiority design. Children (age 5–16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or |
| doi_str_mv | 10.1136/bmjpo-2017-000028 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_489176</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2024015929</sourcerecordid><originalsourceid>FETCH-LOGICAL-b552t-8474b52b2c3e97519463c9422096d0663a0fcb9645dca97e9d5d4a1ad1bd433c3</originalsourceid><addsrcrecordid>eNqNks1u1DAUhSMEolXpA7BBltiwmEDsOD9mgVRVLSBVYgNry7HvUA-OHWxnqnkzHo_bybS0SEhkk6vkO-faR6coXtLqLaV1-24YN1MoWUW7ssKH9U-KY1YLUYquY08fzEfFaUobRKjoBW_Y8-KIibbuqr4_Ln6dTRN4AzqHcUe2ENOciA--DBNEle0WSI6g8gg-k3WIROk5A5m9DuPkrFYZDFF7D6tttolYT_S1dSaCf09Sns2OTDHkoINbDMg4u2w1GkZYEdzjS6cGcKv9XuvXEG2INu9WJCpvwmgT7tAB-eAcjjla5V4Uz9bKJTg9vE-Kb5cXX88_lVdfPn4-P7sqh6Zhuex5x4eGDUzXILqGCt7WWnDGKtGaqm1rVa31IFreGK1EB8I0hiuqDB0Mr2tdnxTl4ptuYJoHOUU7qriTQVl5-PQDJ5C8F7RrkRf_5DEH80d0J6R4pIY3okLth0WLwAhmH5Fyjy0e_fH2Wn4PW9n0vMYKoMGbg0EMP2dIWWJ4GpxTHsKcJKsYr2gjmED09V_oJszRY5SSYXIdXr7tkKILpWNIKcL6_jC0krc1lPsaytsayqWGqHn18Bb3irvSIbBaANT-h99vJHTuyQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2552743367</pqid></control><display><type>article</type><title>Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial</title><source>BMJ Open Access Journals</source><source>PubMed Central(OpenAccess)</source><source>DOAJ Directory of Open Access Journals</source><source>SWEPUB Freely available online</source><source>EZB Electronic Journals Library</source><creator>Hall, Nigel J ; Eaton, Simon ; Abbo, Olivier ; Arnaud, Alexis P ; Beaudin, Marianne ; Brindle, Mary ; Bütter, Andreana ; Davies, Dafydd ; Jancelewicz, Tim ; Johnson, Kathy ; Keijzer, Richard ; Lapidus-Krol, Eveline ; Offringa, Martin ; Piché, Nelson ; Rintala, Risto ; Skarsgard, Erik ; Svensson, Jan F ; Ungar, Wendy J ; Wester, Tomas ; Willan, Andrew R ; Zani, Augusto ; St Peter, Shawn D ; Pierro, Agostino</creator><creatorcontrib>Hall, Nigel J ; Eaton, Simon ; Abbo, Olivier ; Arnaud, Alexis P ; Beaudin, Marianne ; Brindle, Mary ; Bütter, Andreana ; Davies, Dafydd ; Jancelewicz, Tim ; Johnson, Kathy ; Keijzer, Richard ; Lapidus-Krol, Eveline ; Offringa, Martin ; Piché, Nelson ; Rintala, Risto ; Skarsgard, Erik ; Svensson, Jan F ; Ungar, Wendy J ; Wester, Tomas ; Willan, Andrew R ; Zani, Augusto ; St Peter, Shawn D ; Pierro, Agostino</creatorcontrib><description>BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.MethodsMulticentre, international, randomised controlled trial with a non-inferiority design. Children (age 5–16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.DiscussionThe APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.Trial registration numberclinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.</description><identifier>ISSN: 2399-9772</identifier><identifier>EISSN: 2399-9772</identifier><identifier>DOI: 10.1136/bmjpo-2017-000028</identifier><identifier>PMID: 29637088</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Antibiotics ; Appendectomy ; Appendicitis ; Children & youth ; Medical diagnosis ; Medicin och hälsovetenskap ; Patients ; Pediatrics ; Protocol ; Surgery</subject><ispartof>BMJ PAEDIATRICS OPEN, 2017, Vol.1 (1), p.bmjpo-2017-000028</ispartof><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</rights><rights>2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b552t-8474b52b2c3e97519463c9422096d0663a0fcb9645dca97e9d5d4a1ad1bd433c3</citedby><cites>FETCH-LOGICAL-b552t-8474b52b2c3e97519463c9422096d0663a0fcb9645dca97e9d5d4a1ad1bd433c3</cites><orcidid>0000-0001-8570-9374</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjpaedsopen.bmj.com/content/1/1/bmjpo-2017-000028.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjpaedsopen.bmj.com/content/1/1/bmjpo-2017-000028.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,552,727,780,784,864,885,4024,27549,27550,27923,27924,27925,53791,53793,77601,77632</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29637088$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:146354590$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Hall, Nigel J</creatorcontrib><creatorcontrib>Eaton, Simon</creatorcontrib><creatorcontrib>Abbo, Olivier</creatorcontrib><creatorcontrib>Arnaud, Alexis P</creatorcontrib><creatorcontrib>Beaudin, Marianne</creatorcontrib><creatorcontrib>Brindle, Mary</creatorcontrib><creatorcontrib>Bütter, Andreana</creatorcontrib><creatorcontrib>Davies, Dafydd</creatorcontrib><creatorcontrib>Jancelewicz, Tim</creatorcontrib><creatorcontrib>Johnson, Kathy</creatorcontrib><creatorcontrib>Keijzer, Richard</creatorcontrib><creatorcontrib>Lapidus-Krol, Eveline</creatorcontrib><creatorcontrib>Offringa, Martin</creatorcontrib><creatorcontrib>Piché, Nelson</creatorcontrib><creatorcontrib>Rintala, Risto</creatorcontrib><creatorcontrib>Skarsgard, Erik</creatorcontrib><creatorcontrib>Svensson, Jan F</creatorcontrib><creatorcontrib>Ungar, Wendy J</creatorcontrib><creatorcontrib>Wester, Tomas</creatorcontrib><creatorcontrib>Willan, Andrew R</creatorcontrib><creatorcontrib>Zani, Augusto</creatorcontrib><creatorcontrib>St Peter, Shawn D</creatorcontrib><creatorcontrib>Pierro, Agostino</creatorcontrib><title>Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial</title><title>BMJ PAEDIATRICS OPEN</title><addtitle>BMJ Paediatr Open</addtitle><description>BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.MethodsMulticentre, international, randomised controlled trial with a non-inferiority design. Children (age 5–16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.DiscussionThe APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.Trial registration numberclinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.</description><subject>Antibiotics</subject><subject>Appendectomy</subject><subject>Appendicitis</subject><subject>Children & youth</subject><subject>Medical diagnosis</subject><subject>Medicin och hälsovetenskap</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Protocol</subject><subject>Surgery</subject><issn>2399-9772</issn><issn>2399-9772</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>D8T</sourceid><recordid>eNqNks1u1DAUhSMEolXpA7BBltiwmEDsOD9mgVRVLSBVYgNry7HvUA-OHWxnqnkzHo_bybS0SEhkk6vkO-faR6coXtLqLaV1-24YN1MoWUW7ssKH9U-KY1YLUYquY08fzEfFaUobRKjoBW_Y8-KIibbuqr4_Ln6dTRN4AzqHcUe2ENOciA--DBNEle0WSI6g8gg-k3WIROk5A5m9DuPkrFYZDFF7D6tttolYT_S1dSaCf09Sns2OTDHkoINbDMg4u2w1GkZYEdzjS6cGcKv9XuvXEG2INu9WJCpvwmgT7tAB-eAcjjla5V4Uz9bKJTg9vE-Kb5cXX88_lVdfPn4-P7sqh6Zhuex5x4eGDUzXILqGCt7WWnDGKtGaqm1rVa31IFreGK1EB8I0hiuqDB0Mr2tdnxTl4ptuYJoHOUU7qriTQVl5-PQDJ5C8F7RrkRf_5DEH80d0J6R4pIY3okLth0WLwAhmH5Fyjy0e_fH2Wn4PW9n0vMYKoMGbg0EMP2dIWWJ4GpxTHsKcJKsYr2gjmED09V_oJszRY5SSYXIdXr7tkKILpWNIKcL6_jC0krc1lPsaytsayqWGqHn18Bb3irvSIbBaANT-h99vJHTuyQ</recordid><startdate>2017</startdate><enddate>2017</enddate><creator>Hall, Nigel J</creator><creator>Eaton, Simon</creator><creator>Abbo, Olivier</creator><creator>Arnaud, Alexis P</creator><creator>Beaudin, Marianne</creator><creator>Brindle, Mary</creator><creator>Bütter, Andreana</creator><creator>Davies, Dafydd</creator><creator>Jancelewicz, Tim</creator><creator>Johnson, Kathy</creator><creator>Keijzer, Richard</creator><creator>Lapidus-Krol, Eveline</creator><creator>Offringa, Martin</creator><creator>Piché, Nelson</creator><creator>Rintala, Risto</creator><creator>Skarsgard, Erik</creator><creator>Svensson, Jan F</creator><creator>Ungar, Wendy J</creator><creator>Wester, Tomas</creator><creator>Willan, Andrew R</creator><creator>Zani, Augusto</creator><creator>St Peter, Shawn D</creator><creator>Pierro, Agostino</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope><orcidid>https://orcid.org/0000-0001-8570-9374</orcidid></search><sort><creationdate>2017</creationdate><title>Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial</title><author>Hall, Nigel J ; Eaton, Simon ; Abbo, Olivier ; Arnaud, Alexis P ; Beaudin, Marianne ; Brindle, Mary ; Bütter, Andreana ; Davies, Dafydd ; Jancelewicz, Tim ; Johnson, Kathy ; Keijzer, Richard ; Lapidus-Krol, Eveline ; Offringa, Martin ; Piché, Nelson ; Rintala, Risto ; Skarsgard, Erik ; Svensson, Jan F ; Ungar, Wendy J ; Wester, Tomas ; Willan, Andrew R ; Zani, Augusto ; St Peter, Shawn D ; Pierro, Agostino</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b552t-8474b52b2c3e97519463c9422096d0663a0fcb9645dca97e9d5d4a1ad1bd433c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Antibiotics</topic><topic>Appendectomy</topic><topic>Appendicitis</topic><topic>Children & youth</topic><topic>Medical diagnosis</topic><topic>Medicin och hälsovetenskap</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Protocol</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hall, Nigel J</creatorcontrib><creatorcontrib>Eaton, Simon</creatorcontrib><creatorcontrib>Abbo, Olivier</creatorcontrib><creatorcontrib>Arnaud, Alexis P</creatorcontrib><creatorcontrib>Beaudin, Marianne</creatorcontrib><creatorcontrib>Brindle, Mary</creatorcontrib><creatorcontrib>Bütter, Andreana</creatorcontrib><creatorcontrib>Davies, Dafydd</creatorcontrib><creatorcontrib>Jancelewicz, Tim</creatorcontrib><creatorcontrib>Johnson, Kathy</creatorcontrib><creatorcontrib>Keijzer, Richard</creatorcontrib><creatorcontrib>Lapidus-Krol, Eveline</creatorcontrib><creatorcontrib>Offringa, Martin</creatorcontrib><creatorcontrib>Piché, Nelson</creatorcontrib><creatorcontrib>Rintala, Risto</creatorcontrib><creatorcontrib>Skarsgard, Erik</creatorcontrib><creatorcontrib>Svensson, Jan F</creatorcontrib><creatorcontrib>Ungar, Wendy J</creatorcontrib><creatorcontrib>Wester, Tomas</creatorcontrib><creatorcontrib>Willan, Andrew R</creatorcontrib><creatorcontrib>Zani, Augusto</creatorcontrib><creatorcontrib>St Peter, Shawn D</creatorcontrib><creatorcontrib>Pierro, Agostino</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>BMJ PAEDIATRICS OPEN</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hall, Nigel J</au><au>Eaton, Simon</au><au>Abbo, Olivier</au><au>Arnaud, Alexis P</au><au>Beaudin, Marianne</au><au>Brindle, Mary</au><au>Bütter, Andreana</au><au>Davies, Dafydd</au><au>Jancelewicz, Tim</au><au>Johnson, Kathy</au><au>Keijzer, Richard</au><au>Lapidus-Krol, Eveline</au><au>Offringa, Martin</au><au>Piché, Nelson</au><au>Rintala, Risto</au><au>Skarsgard, Erik</au><au>Svensson, Jan F</au><au>Ungar, Wendy J</au><au>Wester, Tomas</au><au>Willan, Andrew R</au><au>Zani, Augusto</au><au>St Peter, Shawn D</au><au>Pierro, Agostino</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial</atitle><jtitle>BMJ PAEDIATRICS OPEN</jtitle><addtitle>BMJ Paediatr Open</addtitle><date>2017</date><risdate>2017</risdate><volume>1</volume><issue>1</issue><spage>bmjpo-2017-000028</spage><pages>bmjpo-2017-000028-</pages><issn>2399-9772</issn><eissn>2399-9772</eissn><abstract>BackgroundAppendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.MethodsMulticentre, international, randomised controlled trial with a non-inferiority design. Children (age 5–16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.DiscussionThe APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.Trial registration numberclinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>29637088</pmid><doi>10.1136/bmjpo-2017-000028</doi><orcidid>https://orcid.org/0000-0001-8570-9374</orcidid><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; PubMed Central(OpenAccess); DOAJ Directory of Open Access Journals; SWEPUB Freely available online; EZB Electronic Journals Library |
| subjects | Antibiotics Appendectomy Appendicitis Children & youth Medical diagnosis Medicin och hälsovetenskap Patients Pediatrics Protocol Surgery |
| title | Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial |
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