Endometrial Neoplasms
Conditions
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.
Interventions
PROCEDURERobotic surgery
Minimal invasive surgery performed with daVinci robotic system
PROCEDUREAbdominal surgery
Current gold standard
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years of age * High risk endometrial cancer
Exclusion criteria
* WHO performance\>1 * Severe comorbidity, ASA\>3 * Unable to understand information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of harvested lymph nodes | 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of cancer | 3 years | Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site |
| Lymphatic side-effects | 2 years | 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 |
| Quality of life | 2 years | All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery |
| Healthcare cost | 2 years | All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year. |
Countries
Sweden
Outcome results
None listed