Surgery--Complications
Conditions
Keywords
radical hysterectomy, minimally invasive surgery
Brief summary
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).
Detailed description
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).
Interventions
PROCEDUREOpen radical hysterectomy
PROCEDURElaparoscopic radical hysterectomy
PROCEDURERobotically assisted radical hysterectomy
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer. * Subjected to Radical Hysterectomy.
Exclusion criteria
* Pregnant women in which a RH was performed at the time of caesarean section. * Previous chemotherapy treatment * Previous pelvic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival. | up to 240 months | From date of randomization until the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | up to 240 months | from surgery to time of recurrence or time of death(all causes) |
| Cancer specific survival | up to 240 month | from surgery to time of death( cervical cancer related) |
| surgical complication Rate | up to 28 days | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Outcome results
None listed