To Örebro University

oru.seÖrebro University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Department of Surgery in Linköping and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
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.
Show others and affiliations
2024 (English)In: Diseases of the esophagus, ISSN 1120-8694, E-ISSN 1442-2050, Vol. 37, no 6, article id doae010Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
John Wiley & Sons, 2024. Vol. 37, no 6, article id doae010
Keywords [en]
complications, esophagectomy, surgery, trials
National Category
Surgery
Identifiers
URN: urn:nbn:se:oru:diva-111663DOI: 10.1093/dote/doae010ISI: 001163656400001PubMedID: 38366900Scopus ID: 2-s2.0-85195052888OAI: oai:DiVA.org:oru-111663DiVA, id: diva2:1839496
Funder
Swedish Cancer Society, CAN 2021/1086
Note

Study protocol

Available from: 2024-02-21 Created: 2024-02-21 Last updated: 2025-02-06Bibliographically approved

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full textPubMedScopus

Authority records

Szabo, Eva

Search in DiVA

By author/editor
Szabo, Eva
By organisation
School of Medical SciencesÖrebro University Hospital
In the same journal
Diseases of the esophagus
Surgery

Search outside of DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 25 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf