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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early stage Cervical Cancer- Open Radical Hysterectomy(RH) | Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a open RH at our institution as primary treatment were included in the study |
| |
| Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy | Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a laparoscopic RH at our institution as primary treatment were included in the study |
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| Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH) | Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a robotically assisted RH at our institution as primary treatment were included in the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open radical hysterectomy | Procedure |
| ||
| laparoscopic radical hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival. | From date of randomization until the date of death from any cause. | up to 240 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | from surgery to time of recurrence or time of death(all causes) | up to 240 months |
| Cancer specific survival | from surgery to time of death( cervical cancer related) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gil-Moreno, MD, PhD | Hospital Vall D'Hberon | Principal Investigator |
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| Procedure |
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| Robotically assisted radical hysterectomy | Procedure |
|
| up to 240 month |
| surgical complication Rate | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 28 days |