Authors
Pedro T Ramirez, Michael Frumovitz, Rene Pareja, Aldo Lopez, Marcelo Vieira, Reitan Ribeiro, Alessandro Buda, Xiaojian Yan, Yao Shuzhong, Naven Chetty, David Isla, Mariano Tamura, Tao Zhu, Kristy P Robledo, Val Gebski, Rebecca Asher, Vanessa Behan, James L Nicklin, Robert L Coleman, Andreas Obermair
Publication date
2018/11/15
Journal
New England Journal of Medicine
Volume
379
Issue
20
Pages
1895-1904
Publisher
Massachusetts Medical Society
Description
Background
There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer.
Methods
In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than −7.2 percentage points (i.e., closer to zero …
Scholar articles
PT Ramirez, M Frumovitz, R Pareja, A Lopez, M Vieira… - New England Journal of Medicine, 2018