Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01)
| Autor: | Halim Abou Hanna, Charles-Henri Marty-Ané, Pierre-Emmanuel Falcoz, Alain Bernard, Pascal-Alexandre Thomas, Jalal Assouad, Christophe Jayle, Pierre-Benoit Pagès, Ludwig Serge Serge Aho, Jean-Marc Baste, Anne-Claire Bertaux, Jérome Mouroux, François Tronc, Marc Filaire, Richard de Latour, Pierre Magdaleinat |
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| Přispěvatelé: | Service de chirurgie cardio-vasculaire et thoracique (CHU Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service d'épidémiologie et d'hygiène hospitalières (CHU de Dijon), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de chirurgie générale et thoracique [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Département de chirurgie thoracique (Centre Centre Jean Perrin, Clermont-Ferrand), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER-UNICANCER, Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie thoracique (HCL, Hôpital Louis Pradel, Bron), Hospices Civils de Lyon (HCL)-Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Service de chirurgie cardio-vasculaire et thoracique (CHU de Poitiers), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service de Chirurgie thoracique, Centre Hospitalier Universitaire de Nice (CHU Nice), Departement de chirurgie thoracique et des maladies de l'oesophage [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Dpt chirurgie thoracique [CHU Strasbourg], CHU Strasbourg, Département Chirurgie cardiaque, thoracique et vasculaire (CHU de Montpellier), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Service de chirurgie thoracique [CHU Tenon], Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_treatment Cost-Benefit Analysis 030204 cardiovascular system & hematology law.invention 0302 clinical medicine Postoperative Complications Randomized controlled trial Statistics and research methods law Carcinoma Non-Small-Cell Lung Protocol Thoracotomy Pneumonectomy medicine.diagnostic_test Thoracic Surgery Video-Assisted General Medicine 3. Good health Treatment Outcome Cardiothoracic surgery Female Non small cell France Adult medicine.medical_specialty VATS lobectomy Operative Time Respiratory tract tumours [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery STATISTICS & RESEARCH METHODS 03 medical and health sciences medicine Thoracoscopy Humans Lung cancer Retrospective Studies Protocol (science) business.industry Reproducibility of Results Length of Stay medicine.disease Survival Analysis Surgery 030228 respiratory system business Health economics |
| Zdroj: | BMJ Open BMJ Open, 2017, 7 (6), pp.e012963. ⟨10.1136/bmjopen-2016-012963⟩ BMJ Open, BMJ Publishing Group, 2017, 7 (6), pp.e012963. ⟨10.1136/bmjopen-2016-012963⟩ |
| ISSN: | 2044-6055 |
| Popis: | IF 2.562; International audience; Introduction In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact.Methods and analysis The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients.Ethics and dissemination The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals.Trial registration number NCT02502318. |
| Databáze: | OpenAIRE |
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