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Drain-free mastectomy and flap fixation: The interim analysis of a randomized controlled noninferiority trial.

Merel A Spiekerman van WeezelenburgLisa de RooijLoeki AldenhovenSander M J van KuijkElisabeth R M van HaarenAlfred JanssenYvonne L J VissersGeerard L BeetsJames van Bastelaar
Published in: Journal of surgical oncology (2024)
The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.
Keyphrases
  • breast reconstruction
  • public health
  • study protocol
  • healthcare
  • randomized controlled trial
  • risk factors
  • minimally invasive
  • phase iii
  • clinical trial
  • mental health
  • phase ii
  • monte carlo
  • soft tissue
  • double blind