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Sökning: onr:"swepub:oai:DiVA.org:oru-111663" > Randomized controll...

Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial

Hedberg, Jakob (författare)
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden,Uppsala Univ, Sweden
Sundbom, Magnus (författare)
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden,Uppsala Univ, Sweden
Edholm, David (författare)
Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US
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Aahlin, Eirik Kjus (författare)
Department of GI and HPB Surgery, Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway; Department of GI and HPB Surgery, University Hospital of Northern Norway, Tromsø, Norway,Univ Tromso, Norway; Univ Hosp Northern Norway, Norway
Szabo, Eva, PhD, 1973- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Surgery,Orebro Univ, Sweden
Lindberg, Fredrik (författare)
Department of Surgical and Perioperative Sciences Surgery, Umeå University, Umeå, Sweden,Umea Univ, Sweden
Johnsen, Gjermund (författare)
Department of Gastrointestinal Surgery, Norwegian University of Science and Technology, Trondheim, Norway,Norwegian Univ Sci & Technol, Norway
Førland, Dag Tidemann (författare)
Department of Pediatric and Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway,Oslo Univ Hosp, Norway
Johansson, Jan (författare)
Department of Surgery, Skane University Hospital, Lund, Sweden,Skane Univ Hosp, Sweden
Kauppila, Joonas H (författare)
Department of Surgery, University of Oulu and Oulu University Hospital, Oulu, Finland,Univ Oulu, Finland; Oulu Univ Hosp, Finland
Svendsen, Lars Bo (författare)
Department of Surgery and Transplantation, Copenhagen University Hospital, Copenhagen, Denmark,Copenhagen Univ Hosp, Denmark
Nilsson, Magnus (författare)
Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Stockholm, Sweden; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK,Karolinska Inst, Sweden; Univ Oxford, England
Lindblad, Mats (författare)
Department of Clinical Science, Intervention and Technology, Division of Surgery, Karolinska Institutet, Stockholm, Sweden,Karolinska Inst, Sweden
Lagergren, Pernilla (författare)
Karolinska Institutet
Larsen, Michael Hareskov (författare)
Department of Surgery, Odense University Hospital, Odense, Denmark,Odense Univ Hosp, Denmark
Åkesson, Oscar (författare)
Department of Surgery, Skane University Hospital, Lund, Sweden,Skane Univ Hosp, Sweden
Löfdahl, Per (författare)
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden,Sahlgrens Univ Hosp, Sweden
Mala, Tom (författare)
Department of Pediatric and Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway,Oslo Univ Hosp, Norway
Achiam, Michael Patrick (författare)
Department of Surgery and Transplantation, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark,Copenhagen Univ Hosp, Denmark; Univ Copenhagen, Denmark
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 (creator_code:org_t)
2024
2024
Engelska.
Ingår i: Diseases of the esophagus. - : John Wiley & Sons. - 1120-8694 .- 1442-2050.
Relaterad länk:
https://doi.org/10.1...
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https://urn.kb.se/re...
https://doi.org/10.1...
https://urn.kb.se/re...
http://kipublication...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Esophagectomy 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

complications
esophagectomy
surgery
trials

Publikations- och innehållstyp

ref (ämneskategori)
art (ämneskategori)

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