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
healthcare
study protocol
randomized controlled trial
phase iii
risk factors
minimally invasive
clinical trial
phase ii
mental health
open label
soft tissue