Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Neoplasms
- Sponsor
- Karolinska Institutet
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Number of harvested lymph nodes
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.
Detailed Description
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.
Investigators
Henrik Falconer
MD, PhD
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •18-75 years of age
- •High risk endometrial cancer
Exclusion Criteria
- •WHO performance\>1
- •Severe comorbidity, ASA\>3
- •Unable to understand information
Outcomes
Primary Outcomes
Number of harvested lymph nodes
Time Frame: 2 years
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
Secondary Outcomes
- Lymphatic side-effects(2 years)
- Quality of life(2 years)
- Healthcare cost(2 years)
- Recurrence of cancer(3 years)