Endometrium Cancer Clinical Trial
Official title:
Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
Verified date | June 2019 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | September 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere | P.O.Box 2000 |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the operation time | From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours | ||
Secondary | bleeding | Duration of hospital stay, an expected average of 5 weeks | ||
Secondary | Number of participants with adverse events | Duration of hospital stay, an expected average of 5 weeks | ||
Secondary | Pain | visual analogue scale | Duration of hospital stay, an expected average of 5 weeks | |
Secondary | pelvic lymph node volumes | Duration of hospital stay, an expected average of 5 weeks |
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