Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)
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.
Procedure: Robotic surgery
Procedure: Abdominal surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer|
- Number of harvested lymph nodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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
- Recurrence of cancer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
- Lymphatic side-effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Robotic surgery
Experimental method, to be compared with standard care
|Procedure: Robotic surgery|
|Active Comparator: Abdominal surgery||
Procedure: Abdominal surgery
Current gold standard
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847703
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Henrik Falconer, MD, PhD +46707742146 firstname.lastname@example.org|
|Principal Investigator: Henrik Falconer, MD, PhD|
|Principal Investigator:||Henrik Falconer, MD, PhD||Karolinska Institutet|