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

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 accorda... Mehr ...

Verfasser: Smits, F Jasmijn
Henry, Anne Claire
Besselink, Marc G
Busch, Olivier R
van Eijck, Casper H
Arntz, Mark
Bollen, Thomas L
van Delden, Otto M
van den Heuvel, Daniel
van der Leij, Christiaan
van Lienden, Krijn P
Moelker, Adriaan
Bonsing, Bert A
Borel Rinkes, Inne H
Bosscha, Koop
van Dam, Ronald M
Derksen, Wouter J M
den Dulk, Marcel
Festen, Sebastiaan
Groot Koerkamp, Bas
de Haas, Robbert J
Hagendoorn, Jeroen
van der Harst, Erwin
de Hingh, Ignace H
Kazemier, Geert
van der Kolk, Marion
Liem, Mike
Lips, Daan J
Luyer, Misha D
de Meijer, Vincent E
Mieog, J Sven
Nieuwenhuijs, Vincent B
Patijn, Gijs A
Te Riele, Wouter W
Roos, Daphne
Schreinemakers, Jennifer M
Stommel, Martijn W J
Wit, Fennie
Zonderhuis, Babs A
Daamen, Lois A
van Werkhoven, C Henri
Molenaar, I Quintus
van Santvoort, Hjalmar C
Dokumenttyp: Artikel
Erscheinungsdatum: 2022
Reihe/Periodikum: Dutch Pancreatic Cancer Group , Smits , F J , Henry , A C , Besselink , M G , Busch , O R , van Eijck , C H , Arntz , M , Bollen , T L , van Delden , O M , van den Heuvel , D , van der Leij , C , van Lienden , K P , Moelker , A , Bonsing , B A , Borel Rinkes , I H , Bosscha , K , van Dam , R M , Derksen , W J M , den Dulk , M , Festen , S , Groot Koerkamp , B , de Haas , R J , Hagendoorn , J , van der Harst , E , de Hingh , I H , Kazemier , G , van der Kolk , M , Liem , M , Lips , D J , Luyer , M D , de Meijer , V E , Mieog , J S , Nieuwenhuijs , V B , Patijn , G A , Te Riele , W W , Roos , D , Schreinemakers , J M , Stommel , M W J , Wit , F , Zonderhuis , B A , Daamen , L A , van Werkhoven , C H , Molenaar , I Q & van Santvoort , H C 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. 14-20 . https://doi.org/10.1016/S0140-6736(22)00182-9
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28778461
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://hdl.handle.net/11370/3c818e08-c96d-457a-a812-8d49d50d6d92

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. ...