Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endometrium Cancer
- Sponsor
- Tampere University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- the operation time
- Last Updated
- 6 years ago
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
Investigators
Minna Mäenpää
Principal Investigator
Tampere University Hospital
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
Outcomes
Primary Outcomes
the operation time
Time Frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary Outcomes
- 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)
- pelvic lymph node volumes(Duration of hospital stay, an expected average of 5 weeks)