Prospective controlled study (Canadian Task Force II-2) : Comparison analysis regarding surgical outcomes, complications, overall survival (OS), disease free survival (DFS) and cancer specific survival between patients subjected to radical Hysterectomy either by open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).
Study Objective: To analyse the effect that the introduction of minimally invasive procedures has had on surgical and oncological outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer center Design: A prospective controlled study (Canadian Task Force II-2) Setting: A university teaching hospital Patients: All patients that underwent RH as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients. Interventions: Patients underwent an open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).
Study Type
OBSERVATIONAL
Enrollment
188
Overall survival.
From date of randomization until the date of death from any cause.
Time frame: up to 240 months
Disease free survival
from surgery to time of recurrence or time of death(all causes)
Time frame: up to 240 months
Cancer specific survival
from surgery to time of death( cervical cancer related)
Time frame: up to 240 month
surgical complication Rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 28 days
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