Christophe Mariette1,2,3,4, Sheraz Markar5, Tienhan Sandrine Dabakuyo-Yonli6,7, Bernard Meunier8, Denis Pezet9, Denis Collet10, Xavier Benoit D'Journo11, Cécile Brigand12, Thierry Perniceni13, Nicolas Carrere14, Jean Yves Mabrut15, Simon Msika16, Frédérique Peschaud17, Michel Prudhomme18, Franck Bonnetain19, Guillaume Piessen1,2,3. 1. Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, University Lille, Lille, France. 2. UMR-S 1172-JPARC-Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer, University Lille, Lille, France. 3. Inserm, UMR-S 1172, Lille, France. 4. SIRIC OncoLille, Lille, France. 5. Department of Surgery and Cancer, Imperial College, London, United Kingdom. 6. Epidemiology and Quality of Life Unit, INSERM 1231 Centre Georges François Leclerc, Dijon, France. 7. National Clinical Research Platform for Quality of Life in Oncology, Lille, France. 8. Department of Hepatobiliary and Digestive Surgery, CHU of Rennes, University of Rennes 1, Rennes, France. 9. Department of Digestive and Hepatobiliary Surgery, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. 10. Department of Digestive Surgery, Haut Lévèque University Hospital, Bordeaux, France. 11. Department of Thoracic Surgery, Hôpital Nord, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France. 12. Department of Digestive Surgery, Strasbourg University, Strasbourg, France. 13. Department of Digestive Surgery, Institut Mutualiste Montsouris, Paris, France. 14. Department of Digestive Surgery, Purpan Hospital, CHU Toulouse, Université Toulouse III, CRCT UMR, Toulouse, France. 15. Department of General Surgery and Liver Transplantation, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Université Lyon 1, Lyon, France. 16. Department of Digestive and General Surgery, CHU Louis Mourier, AP-HP, Université Paris 7, Denis Diderot PRES Sorbonne Paris Cité, Colombes, France. 17. Department of Surgery and Oncology, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Université de Versailles, Boulogne-Billancourt, France. 18. Digestive Surgery Department, CHU Nîmes, Nîmes, France. 19. Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.
Abstract
BACKGROUND:Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. OBJECTIVES: The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. METHODS: We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. RESULTS: The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. CONCLUSIONS:Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.
RCT Entities:
BACKGROUND: Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. OBJECTIVES: The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. METHODS: We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. RESULTS: The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. CONCLUSIONS: Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.
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