The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.
Identifieur interne : 000358 ( PubMed/Corpus ); précédent : 000357; suivant : 000359The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.
Auteurs : Ismael Diez Del Val ; Carlos Loureiro ; Peter MccullochSource :
- International journal of surgery (London, England) [ 1743-9159 ] ; 2015.
English descriptors
- KwdEn :
- MESH :
- methods : Esophagectomy, Robotics.
- surgery : Esophageal Diseases.
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Operative Time, Prospective Studies, Reproducibility of Results, Retrospective Studies.
Abstract
The early development of innovative surgical procedures is usually reported as retrospective case series, wasting opportunities to provide useful information and introducing bias. We present a report of an innovative procedure in development, using the Prospective Development Study (PDS) format recommended by the IDEAL Collaboration.
DOI: 10.1016/j.ijsu.2015.04.035
PubMed: 25896542
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.</title><author><name sortKey="Diez Del Val, Ismael" sort="Diez Del Val, Ismael" uniqKey="Diez Del Val I" first="Ismael" last="Diez Del Val">Ismael Diez Del Val</name><affiliation><nlm:affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: ismael.diezdelval@osakidetza.net.</nlm:affiliation></affiliation></author><author><name sortKey="Loureiro, Carlos" sort="Loureiro, Carlos" uniqKey="Loureiro C" first="Carlos" last="Loureiro">Carlos Loureiro</name><affiliation><nlm:affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: carlos.loureirogonzalez@osakidetza.net.</nlm:affiliation></affiliation></author><author><name sortKey="Mcculloch, Peter" sort="Mcculloch, Peter" uniqKey="Mcculloch P" first="Peter" last="Mcculloch">Peter Mcculloch</name><affiliation><nlm:affiliation>Nuffield Department of Surgical Science Level 6, John Radcliffe Hospital, Oxford OX3 9DU, UK. Electronic address: peter.mcculloch@nds.ox.ac.uk.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25896542</idno><idno type="pmid">25896542</idno><idno type="doi">10.1016/j.ijsu.2015.04.035</idno><idno type="wicri:Area/PubMed/Corpus">000358</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.</title><author><name sortKey="Diez Del Val, Ismael" sort="Diez Del Val, Ismael" uniqKey="Diez Del Val I" first="Ismael" last="Diez Del Val">Ismael Diez Del Val</name><affiliation><nlm:affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: ismael.diezdelval@osakidetza.net.</nlm:affiliation></affiliation></author><author><name sortKey="Loureiro, Carlos" sort="Loureiro, Carlos" uniqKey="Loureiro C" first="Carlos" last="Loureiro">Carlos Loureiro</name><affiliation><nlm:affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: carlos.loureirogonzalez@osakidetza.net.</nlm:affiliation></affiliation></author><author><name sortKey="Mcculloch, Peter" sort="Mcculloch, Peter" uniqKey="Mcculloch P" first="Peter" last="Mcculloch">Peter Mcculloch</name><affiliation><nlm:affiliation>Nuffield Department of Surgical Science Level 6, John Radcliffe Hospital, Oxford OX3 9DU, UK. Electronic address: peter.mcculloch@nds.ox.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of surgery (London, England)</title><idno type="eISSN">1743-9159</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Esophageal Diseases (surgery)</term><term>Esophagectomy (methods)</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Operative Time</term><term>Prospective Studies</term><term>Reproducibility of Results</term><term>Retrospective Studies</term><term>Robotics (methods)</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Esophagectomy</term><term>Robotics</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Esophageal Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Operative Time</term><term>Prospective Studies</term><term>Reproducibility of Results</term><term>Retrospective Studies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The early development of innovative surgical procedures is usually reported as retrospective case series, wasting opportunities to provide useful information and introducing bias. We present a report of an innovative procedure in development, using the Prospective Development Study (PDS) format recommended by the IDEAL Collaboration.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25896542</PMID><DateCreated><Year>2015</Year><Month>07</Month><Day>03</Day></DateCreated><DateCompleted><Year>2016</Year><Month>03</Month><Day>03</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1743-9159</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><PubDate><Year>2015</Year><Month>Jul</Month></PubDate></JournalIssue><Title>International journal of surgery (London, England)</Title><ISOAbbreviation>Int J Surg</ISOAbbreviation></Journal><ArticleTitle>The IDEAL prospective development study format for reporting surgical innovations. An illustrative case study of robotic oesophagectomy.</ArticleTitle><Pagination><MedlinePgn>104-11</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijsu.2015.04.035</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1743-9191(15)00159-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The early development of innovative surgical procedures is usually reported as retrospective case series, wasting opportunities to provide useful information and introducing bias. We present a report of an innovative procedure in development, using the Prospective Development Study (PDS) format recommended by the IDEAL Collaboration.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We report the development of robotically assisted oesophagectomy by a two-surgeon team from the first robotic case onwards. Key outcomes (blood loss, robotic operating time, lymph node yield, length of stay and complications) are prospectively reported for each patient sequentially. Reasons for rejecting cases for robotic surgery are explained. All changes to technique or indication are highlighted, showing when they occurred and explaining why they were instituted.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The first robotic oesophagectomy was attempted in December 2009. Subsequently 55 oesophagectomies were undertaken, 34 using the robot and 21 without it. Seven deliberate changes in technique occurred during the series. Nodal yield increased markedly after adopting formal mediastinal node dissection and clipping of the thoracic duct. No obvious trends were noted in other outcomes. The robot facilitated Intra-thoracic anastomosis, but mediastinal node dissection showed no advantages due to loss of haptic sensation. Complication rates, R0 rates and nodal yield were considered acceptable.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">Presenting the development experience in this way improved the clarity of transmission of the main learning points for other surgeons, eliminated bias from selective reporting and explained other types of selection bias. The IDEAL Prospective Development Study has clear advantages over standard case series format for presenting uncontrolled early study data from innovative procedures.</AbstractText><CopyrightInformation>Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Diez del Val</LastName><ForeName>Ismael</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: ismael.diezdelval@osakidetza.net.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Loureiro</LastName><ForeName>Carlos</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Esophago-gastric Surgery and Robotic Unit, Service of General and Digestive Surgery, Basurto University Hospital, Avenida, Montevideo, 18, 48013 Bilbao, Spain. Electronic address: carlos.loureirogonzalez@osakidetza.net.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McCulloch</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Nuffield Department of Surgical Science Level 6, John Radcliffe Hospital, Oxford OX3 9DU, UK. Electronic address: peter.mcculloch@nds.ox.ac.uk.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>04</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Int J Surg</MedlineTA><NlmUniqueID>101228232</NlmUniqueID><ISSNLinking>1743-9159</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000369">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004935">Esophageal Diseases</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000601">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016629">Esophagectomy</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D061646">Operative Time</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015203">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012189">Retrospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012371">Robotics</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">IDEAL</Keyword><Keyword MajorTopicYN="N">Methodology</Keyword><Keyword MajorTopicYN="N">Oesophagectomy</Keyword><Keyword MajorTopicYN="N">Robotic</Keyword><Keyword MajorTopicYN="N">Surgery</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>3</Month><Day>13</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>4</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2015</Year><Month>4</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>4</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>4</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>3</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25896542</ArticleId><ArticleId IdType="pii">S1743-9191(15)00159-4</ArticleId><ArticleId IdType="doi">10.1016/j.ijsu.2015.04.035</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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