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dc.contributor.authorHedberg, Jakob
dc.contributor.authorSundbom, Magnus
dc.contributor.authorEdholm, David
dc.contributor.authorAahlin, Eirik Kjus
dc.contributor.authorSzabo, Eva
dc.contributor.authorLindberg, Fredrik
dc.contributor.authorJohnsen, Gjermund
dc.contributor.authorFørland, Dag T.
dc.contributor.authorJohansson, Jan
dc.contributor.authorKauppila, Joonas H
dc.contributor.authorSvendsen, Lars Bo
dc.contributor.authorNilsson, Magnus
dc.contributor.authorLindblad, Mats
dc.contributor.authorLagergren, Pernilla
dc.contributor.authorLarsen, Michael Hareskov
dc.contributor.authorÅkesson, Oscar
dc.contributor.authorLöfdahl, Per
dc.contributor.authorMala, Tom
dc.contributor.authorAchiam, Michael Patrick
dc.date.accessioned2024-08-29T12:04:00Z
dc.date.available2024-08-29T12:04:00Z
dc.date.issued2024-02-16
dc.description.abstractEsophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.en_US
dc.identifier.citationHedberg, Sundbom, Edholm, Aahlin, Szabo, Lindberg, Johnsen, Førland, Johansson, Kauppila, Svendsen, Nilsson, Lindblad, Lagergren, Larsen, Åkesson, Löfdahl, Mala, Achiam. Randomized controlled trial of nasogastric tube use after esophagectomy: Study protocol for the kinetic trial. Diseases of the esophagus. 2024;37(6)en_US
dc.identifier.cristinIDFRIDAID 2277194
dc.identifier.doi10.1093/dote/doae010
dc.identifier.issn1120-8694
dc.identifier.issn1442-2050
dc.identifier.urihttps://hdl.handle.net/10037/34477
dc.language.isoengen_US
dc.publisherOxford University Pressen_US
dc.relation.journalDiseases of the esophagus
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleRandomized controlled trial of nasogastric tube use after esophagectomy: Study protocol for the kinetic trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
Med mindre det står noe annet, er denne innførselens lisens beskrevet som Attribution 4.0 International (CC BY 4.0)