- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847703
Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)
Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Karolinska University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-75 years of age
- High risk endometrial cancer
Exclusion Criteria:
- WHO performance>1
- Severe comorbidity, ASA>3
- Unable to understand information
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robotic surgery
Experimental method, to be compared with standard care
|
Minimal invasive surgery performed with daVinci robotic system
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Active Comparator: Abdominal surgery
Conventional open surgery (laparotomy)
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Current gold standard
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of cancer
Time Frame: 3 years
|
Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
|
3 years
|
Lymphatic side-effects
Time Frame: 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
|
2 years
|
Quality of life
Time Frame: 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
|
2 years
|
Healthcare cost
Time Frame: 2 years
|
All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henrik Falconer, MD, PhD, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/361-31/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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