Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
Not Applicable
- Conditions
- Endometrium Cancer
- Registration Number
- NCT01466777
- Lead Sponsor
- Tampere University Hospital
- 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:
1. bleeding
2. complications
3. conversions
4. number of pelvic lymph nodes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Duration of hospital stay, an expected average of 5 weeks visual analogue scale
pelvic lymph node volumes Duration of hospital stay, an expected average of 5 weeks
Trial Locations
- Locations (1)
Tampere University Hospital
🇫🇮Tampere, P.O.Box 2000, Finland
Tampere University Hospital🇫🇮Tampere, P.O.Box 2000, Finland