Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Conditions
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Surgery--Complications

Intervention / Treatment
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* Procedure: Open radical hysterectomy
* Procedure: laparoscopic radical hysterectomy
* Procedure: Robotically assisted radical hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early stage Cervical Cancer- Open Radical Hysterectomy(RH)<br>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 | Procedure: Open radical hysterectomy<br> <br> |
| Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy<br>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 | Procedure: laparoscopic radical hysterectomy<br> <br> |
| Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH)<br>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 | Procedure: Robotically assisted radical hysterectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival. | From date of randomization until the date of death from any cause. | up to 240 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical hysterectomy, minimally invasive surgery