Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients. The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account. The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer. Secondary endpoints include: bleeding complications conversions number of pelvic lymph nodes

Official Title
-----------------
Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

Conditions
-----------------
Endometrium Cancer

Intervention / Treatment
-----------------
* Procedure: Traditional surgery type
* Procedure: Robotic assisted laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy Gr 1 and 2 differentiation type Exclusion Criteria: The operation cannot be made with an laparoscopy operation Age more than 85 years or young under 30 years patient

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: traditional laparoscopic surgery type<br> | Procedure: Traditional surgery type<br>* Traditional laparoscopic surgery for endometrial cancer<br>|
| Experimental: Robotic assisted operation type<br> | Procedure: Robotic assisted laparoscopic surgery<br>* Robotic assisted laparoscopic surgery for endometrial cancer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the operation time |  | From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding |  | Duration of hospital stay, an expected average of 5 weeks | 
| Number of participants with adverse events |  | Duration of hospital stay, an expected average of 5 weeks | 
| Pain | visual analogue scale | Duration of hospital stay, an expected average of 5 weeks | 
| pelvic lymph node volumes |  | Duration of hospital stay, an expected average of 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications, Conversions, Pelvic lymph node