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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Minimal invasive surgery performed with daVinci robotic system
Current gold standard
Karolinska University Hospital
Stockholm, Sweden
Number of harvested lymph nodes
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
Time frame: 2 years
Recurrence of cancer
Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
Time frame: 3 years
Lymphatic side-effects
Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up
Time frame: 2 years
Quality of life
All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery
Time frame: 2 years
Healthcare cost
All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
Time frame: 2 years
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