Status not kept up to date
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
NCT01466777 · Tampere University Hospital · Updated 6 June 2019
- What is being tested
- Traditional surgery type; Robotic assisted laparoscopic surgery
- For
- Endometrium Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 30 years to 85 years. About 100 people. The full rules are on the registry page.
- Where
- Finland
- When
- Starts or started Nov 2010, ends Sept 2019. Registered 8 Nov 2011.
- Results
- None posted yet.
In the researchers' words
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: 1. bleeding 2. complications 3. conversions 4. number of pelvic lymph nodes
Sites
- Tampere University HospitalTampere, P.O.Box 2000, Finland