Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial
| العنوان: | Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial |
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| المؤلفون: | F Jasmijn Smits, Anne Claire Henry, Marc G Besselink, Olivier R Busch, Casper H van Eijck, Mark Arntz, Thomas L Bollen, Otto M van Delden, Daniel van den Heuvel, Christiaan van der Leij, Krijn P van Lienden, Adriaan Moelker, Bert A Bonsing, Inne H Borel Rinkes, Koop Bosscha, Ronald M van Dam, Wouter J M Derksen, Marcel den Dulk, Sebastiaan Festen, Bas Groot Koerkamp, Robbert J de Haas, Jeroen Hagendoorn, Erwin van der Harst, Ignace H de Hingh, Geert Kazemier, Marion van der Kolk, Mike Liem, Daan J Lips, Misha D Luyer, Vincent E de Meijer, J Sven Mieog, Vincent B Nieuwenhuijs, Gijs A Patijn, Wouter W te Riele, Daphne Roos, Jennifer M Schreinemakers, Martijn W J Stommel, Fennie Wit, Babs A Zonderhuis, Lois A Daamen, C Henri van Werkhoven, I Quintus Molenaar, Hjalmar C van Santvoort, JG Blomjous, MT de Boer, P van den Boezem, S Bouwense, R Bruijnen, CI Buis, M del Chiaro, PP Coene, M Coolsen, F Daams, K Dejong, W Draaisma, HH Eker, AH Elsen, MF Gerhards, H Hartog, FJ Hoogwater, F Imani, S Jenniskens, KP de Jong, TM Karsten, JM Klaase, RHJ de Kleine, CJ van Laarhoven, H van der Lelij, ER Manusama, M Meerdink, M Meijerink, J Nederend, MW Nijkamp, CL Nota, RJ Porte, J Reef, P de Reuver, C van Rijswijk, T Romkens, C Rupert, GP van der Schelling, JP Serafino, LD Vos, MR Vriens, E Beers-Vural, JM Wagtenberg, JH Wijsman, RF de Wilde, CL Wolfgang, HJ Zeh |
| المساهمون: | Surgery, AGEM - Re-generation and cancer of the digestive system, Amsterdam Gastroenterology Endocrinology Metabolism, Radiology and nuclear medicine, CCA - Imaging and biomarkers, ACS - Pulmonary hypertension & thrombosis, Radiology & Nuclear Medicine, MUMC+: DA BV Medisch Specialisten Radiologie (9), MUMC+: MA Heelkunde (9), RS: NUTRIM - R2 - Liver and digestive health, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, CCA -Cancer Center Amsterdam, Groningen Institute for Organ Transplantation (GIOT), Center for Liver, Digestive and Metabolic Diseases (CLDM) |
| المصدر: | The Lancet, 399(10338), 1867-1875. Elsevier Limited The Lancet, 399(10338), 1867-1875. Elsevier Ltd. Lancet, 399(10338), 1867-1875. Elsevier Science The Lancet, 399(10338), 1867-1875. ELSEVIER SCIENCE INC The Lancet (London), 399, 1867-1875 Dutch Pancreatic Cancer Group 2022, ' Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands : an open-label, nationwide, stepped-wedge cluster-randomised trial ', The Lancet, vol. 399, no. 10338, pp. 1867-1875 . https://doi.org/10.1016/S0140-6736Test(22)00182-9 The Lancet, 399(10338), 14-20. ELSEVIER SCIENCE INC The Lancet (London), 399, 10338, pp. 1867-1875 |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Other Research Radboud Institute for Health Sciences [Radboudumc 0], MULTICENTER, Hemorrhage, General Medicine, RESCUE, FISTULA, CANCER, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Pancreatectomy, Postoperative Complications, Treatment Outcome, All institutes and research themes of the Radboud University Medical Center, SDG 3 - Good Health and Well-being, PANCREATICODUODENECTOMY, Drainage, Humans, FAILURE, IN-HOSPITAL MORTALITY, Algorithms, Netherlands |
| الوصف: | Background Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection. Methods We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low-medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671. Findings From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0middot48, 95% CI 0middot38-0middot61; p |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0140-6736 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3d923a354f3f6698db472eeaae2579aTest https://research.vumc.nl/en/publications/4bd6b5e8-b9af-47ca-a59d-9ca789c4dea2Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d3d923a354f3f6698db472eeaae2579a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 01406736 |
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