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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Traditional laparoscopic surgery for endometrial cancer
Robotic assisted laparoscopic surgery for endometrial cancer
Tampere University Hospital
Tampere, P.O.Box 2000, Finland
the operation time
Time frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
bleeding
Time frame: Duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events
Time frame: Duration of hospital stay, an expected average of 5 weeks
Pain
visual analogue scale
Time frame: Duration of hospital stay, an expected average of 5 weeks
pelvic lymph node volumes
Time frame: Duration of hospital stay, an expected average of 5 weeks
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