Unexpected results from randomized clinical trials. Or are they?
Volume 112, Issue 5, Pages 804–805
Jacques Donnez, M.D., Ph.D.
In a recent editorial, Chien (1) asked “How should we deal with unexpected results from randomized trials?” But why use the term “unexpected” at all? Indeed, before Ramirez et al.’s study was published in the New England Journal of Medicine (2), there was no robust evaluation of disease-free or overall survival rates in women with early-stage cervical cancer (FIGO stage IA1 to IB1) treated with the use of either laparatomy or minimal-access surgery (laparoscopic or robot-assisted). In that randomized clinical trial, which included patients with early-stage cervical cancer assigned to either minimally invasive surgery (n = 319) or open surgery (n = 312), minimally invasive radical hysterectomy was associated with lower rates of disease-free and overall survival than open abdominal radical hysterectomy.