Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design
Identifieur interne : 002305 ( Main/Exploration ); précédent : 002304; suivant : 002306Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design
Auteurs : Quentin Denost [France] ; Florence Saillour [France] ; Lindy Masya [Australie] ; Helene Maillou Martinaud [France] ; Stephanie Guillon [France] ; Marion Kret [France] ; Eric Rullier [France] ; Bruno Quintard [France] ; Michael Solomon [Australie]Source :
- BMC Cancer [ 1471-2407 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Australie, Femelle, France, Humains, Mâle, Procédures de chirurgie digestive, Récidive tumorale locale (), Récidive tumorale locale (anatomopathologie), Récidive tumorale locale (épidémiologie), Référenciation, Sujet âgé, Survie sans rechute, Tumeurs du rectum (), Tumeurs du rectum (anatomopathologie), Tumeurs du rectum (épidémiologie).
- MESH :
- anatomopathologie : Récidive tumorale locale, Tumeurs du rectum.
- épidémiologie : Récidive tumorale locale, Tumeurs du rectum.
- Adulte, Adulte d'âge moyen, Australie, Femelle, France, Humains, Mâle, Procédures de chirurgie digestive, Récidive tumorale locale, Référenciation, Sujet âgé, Survie sans rechute, Tumeurs du rectum.
English descriptors
- KwdEn :
- Adult, Aged, Australia, Benchmarking, Digestive System Surgical Procedures, Disease-Free Survival, Female, France, Humans, Male, Middle Aged, Neoplasm Recurrence, Local (epidemiology), Neoplasm Recurrence, Local (pathology), Neoplasm Recurrence, Local (surgery), Rectal Neoplasms (epidemiology), Rectal Neoplasms (pathology), Rectal Neoplasms (surgery).
- MESH :
- epidemiology : Neoplasm Recurrence, Local, Rectal Neoplasms.
- pathology : Neoplasm Recurrence, Local, Rectal Neoplasms.
- surgery : Neoplasm Recurrence, Local, Rectal Neoplasms.
- Adult, Aged, Australia, Benchmarking, Digestive System Surgical Procedures, Disease-Free Survival, Female, France, Humans, Male, Middle Aged.
Abstract
Among patients with rectal cancer, 5–10 % have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10 % recur locally following primary surgery (LRRC). In both cases, patients ‘care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients’ care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients.
The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end points will be concordance rate between French and Australian operative decisions based on the inter-country reading MRI, post-operative mortality and morbidity rates, oncological outcomes based on resection status and one-year overall and disease-free survival, patients’ quality of life and distress level. Qualitative analysis will compare obstacles and facilitators of operative decision-making between both countries.
Benchmarking can be defined as a comparison and learning process which will allow, in the context of PRC-bTME and LRRC, to understand and to share the whole process management of these patientsbetween Farnce and Australia.
Url:
DOI: 10.1186/s12885-016-2286-1
PubMed: 27044252
PubMed Central: 4820920
Affiliations:
- Australie, France
- Aquitaine, Nouvelle-Aquitaine, Nouvelle-Galles du Sud
- Bordeaux, France, Sydney
- Université Bordeaux II, Université de Sydney
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Le document en format XML
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</affiliation>
</author>
<author><name sortKey="Solomon, Michael" sort="Solomon, Michael" uniqKey="Solomon M" first="Michael" last="Solomon">Michael Solomon</name>
<affiliation wicri:level="4"><nlm:aff id="Aff4">Surgical Outcome Research Centre (SOuRCe), Royal Prince Alfred Hospital, University of Sydney, Sydney, New South Wales Australia</nlm:aff>
<orgName type="university">Université de Sydney</orgName>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="Aff7">Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW Australia</nlm:aff>
<country>Australie</country>
<placeName><region type="state">Nouvelle-Galles du Sud</region>
</placeName>
<wicri:cityArea>Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series><title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Australia</term>
<term>Benchmarking</term>
<term>Digestive System Surgical Procedures</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>France</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neoplasm Recurrence, Local (epidemiology)</term>
<term>Neoplasm Recurrence, Local (pathology)</term>
<term>Neoplasm Recurrence, Local (surgery)</term>
<term>Rectal Neoplasms (epidemiology)</term>
<term>Rectal Neoplasms (pathology)</term>
<term>Rectal Neoplasms (surgery)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Australie</term>
<term>Femelle</term>
<term>France</term>
<term>Humains</term>
<term>Mâle</term>
<term>Procédures de chirurgie digestive</term>
<term>Récidive tumorale locale ()</term>
<term>Récidive tumorale locale (anatomopathologie)</term>
<term>Récidive tumorale locale (épidémiologie)</term>
<term>Référenciation</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
<term>Tumeurs du rectum ()</term>
<term>Tumeurs du rectum (anatomopathologie)</term>
<term>Tumeurs du rectum (épidémiologie)</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Récidive tumorale locale</term>
<term>Tumeurs du rectum</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Neoplasm Recurrence, Local</term>
<term>Rectal Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Neoplasm Recurrence, Local</term>
<term>Rectal Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Neoplasm Recurrence, Local</term>
<term>Rectal Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Récidive tumorale locale</term>
<term>Tumeurs du rectum</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Australia</term>
<term>Benchmarking</term>
<term>Digestive System Surgical Procedures</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>France</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Australie</term>
<term>Femelle</term>
<term>France</term>
<term>Humains</term>
<term>Mâle</term>
<term>Procédures de chirurgie digestive</term>
<term>Récidive tumorale locale</term>
<term>Référenciation</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
<term>Tumeurs du rectum</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Among patients with rectal cancer, 5–10 % have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10 % recur locally following primary surgery (LRRC). In both cases, patients ‘care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients’ care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients.</p>
</sec>
<sec><title>Methods/design</title>
<p>The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end points will be concordance rate between French and Australian operative decisions based on the inter-country reading MRI, post-operative mortality and morbidity rates, oncological outcomes based on resection status and one-year overall and disease-free survival, patients’ quality of life and distress level. Qualitative analysis will compare obstacles and facilitators of operative decision-making between both countries.</p>
</sec>
<sec><title>Discussion</title>
<p>Benchmarking can be defined as a comparison and learning process which will allow, in the context of PRC-bTME and LRRC, to understand and to share the whole process management of these patientsbetween Farnce and Australia.</p>
</sec>
<sec><title>Trial registration</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/show/NCT02551471">NCT02551471</ext-link>
. (date of registration: 09/14/2015)</p>
</sec>
</div>
</front>
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<author><name sortKey="Harper, R" uniqKey="Harper R">R Harper</name>
</author>
<author><name sortKey="Jones, Nm" uniqKey="Jones N">NM Jones</name>
</author>
<author><name sortKey="O Athain, A" uniqKey="O Athain A">A O’Cathain</name>
</author>
<author><name sortKey="Thomas, Kj" uniqKey="Thomas K">KJ Thomas</name>
</author>
<author><name sortKey="Usherwood, T" uniqKey="Usherwood T">T Usherwood</name>
</author>
<author><name sortKey="Westlake, L" uniqKey="Westlake L">L Westlake</name>
</author>
</analytic>
</biblStruct>
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</author>
<author><name sortKey="Hahn, Ea" uniqKey="Hahn E">EA Hahn</name>
</author>
<author><name sortKey="Mo, F" uniqKey="Mo F">F Mo</name>
</author>
<author><name sortKey="Hernandez, L" uniqKey="Hernandez L">L Hernandez</name>
</author>
<author><name sortKey="Tulsky, Ds" uniqKey="Tulsky D">DS Tulsky</name>
</author>
<author><name sortKey="Cella, D" uniqKey="Cella D">D Cella</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Donovan, Ka" uniqKey="Donovan K">KA Donovan</name>
</author>
<author><name sortKey="Grassi, L" uniqKey="Grassi L">L Grassi</name>
</author>
<author><name sortKey="Mcginty, Hl" uniqKey="Mcginty H">HL McGinty</name>
</author>
<author><name sortKey="Jacobsen, Pb" uniqKey="Jacobsen P">PB Jacobsen</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Mucchielli, R" uniqKey="Mucchielli R">R Mucchielli</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Norimatsu, M" uniqKey="Norimatsu M">M Norimatsu</name>
</author>
<author><name sortKey="Pigem, N" uniqKey="Pigem N">N Pigem</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Barbin, L" uniqKey="Barbin L">L Barbin</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Dindo, D" uniqKey="Dindo D">D Dindo</name>
</author>
<author><name sortKey="Demartines, N" uniqKey="Demartines N">N Demartines</name>
</author>
<author><name sortKey="Clavien, Pa" uniqKey="Clavien P">PA Clavien</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
</country>
<region><li>Aquitaine</li>
<li>Nouvelle-Aquitaine</li>
<li>Nouvelle-Galles du Sud</li>
</region>
<settlement><li>Bordeaux</li>
<li>France</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université Bordeaux II</li>
<li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Denost, Quentin" sort="Denost, Quentin" uniqKey="Denost Q" first="Quentin" last="Denost">Quentin Denost</name>
</region>
<name sortKey="Denost, Quentin" sort="Denost, Quentin" uniqKey="Denost Q" first="Quentin" last="Denost">Quentin Denost</name>
<name sortKey="Denost, Quentin" sort="Denost, Quentin" uniqKey="Denost Q" first="Quentin" last="Denost">Quentin Denost</name>
<name sortKey="Guillon, Stephanie" sort="Guillon, Stephanie" uniqKey="Guillon S" first="Stephanie" last="Guillon">Stephanie Guillon</name>
<name sortKey="Guillon, Stephanie" sort="Guillon, Stephanie" uniqKey="Guillon S" first="Stephanie" last="Guillon">Stephanie Guillon</name>
<name sortKey="Kret, Marion" sort="Kret, Marion" uniqKey="Kret M" first="Marion" last="Kret">Marion Kret</name>
<name sortKey="Martinaud, Helene Maillou" sort="Martinaud, Helene Maillou" uniqKey="Martinaud H" first="Helene Maillou" last="Martinaud">Helene Maillou Martinaud</name>
<name sortKey="Martinaud, Helene Maillou" sort="Martinaud, Helene Maillou" uniqKey="Martinaud H" first="Helene Maillou" last="Martinaud">Helene Maillou Martinaud</name>
<name sortKey="Quintard, Bruno" sort="Quintard, Bruno" uniqKey="Quintard B" first="Bruno" last="Quintard">Bruno Quintard</name>
<name sortKey="Rullier, Eric" sort="Rullier, Eric" uniqKey="Rullier E" first="Eric" last="Rullier">Eric Rullier</name>
<name sortKey="Rullier, Eric" sort="Rullier, Eric" uniqKey="Rullier E" first="Eric" last="Rullier">Eric Rullier</name>
<name sortKey="Saillour, Florence" sort="Saillour, Florence" uniqKey="Saillour F" first="Florence" last="Saillour">Florence Saillour</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Masya, Lindy" sort="Masya, Lindy" uniqKey="Masya L" first="Lindy" last="Masya">Lindy Masya</name>
</region>
<name sortKey="Solomon, Michael" sort="Solomon, Michael" uniqKey="Solomon M" first="Michael" last="Solomon">Michael Solomon</name>
<name sortKey="Solomon, Michael" sort="Solomon, Michael" uniqKey="Solomon M" first="Michael" last="Solomon">Michael Solomon</name>
</country>
</tree>
</affiliations>
</record>
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