Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
18 Years
75 Years
Female
Endometrial Neoplasms
Trial Information
Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical
safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).
Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous)
are randomized to either RAL or AS. Both groups will undergo complete surgical staging
(hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)
Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints:
Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost,
surgical morbidity.
Inclusion Criteria:
- 18-75 years of age
- High risk endometrial cancer
Exclusion Criteria:
- WHO performance>1
- Severe comorbidity, ASA>3
- Unable to understand information
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of harvested lymph nodes
Outcome Description:
Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Henrik Falconer, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Karolinska Institutet
Authority:
Sweden: Regional Ethical Review Board
Study ID:
2013/361-31/1
NCT ID:
NCT01847703
Start Date:
April 2013
Completion Date:
April 2018
Related Keywords:
- Endometrial Neoplasms
- Neoplasms
- Endometrial Neoplasms
- Adenoma
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