Robotic Versus Abdominal Surgery for Endometrial Cancer
NCT ID: NCT01847703
Last Updated: 2018-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2013-04-30
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic surgery
Experimental method, to be compared with standard care
Robotic surgery
Minimal invasive surgery performed with daVinci robotic system
Abdominal surgery
Conventional open surgery (laparotomy)
Abdominal surgery
Current gold standard
Interventions
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Robotic surgery
Minimal invasive surgery performed with daVinci robotic system
Abdominal surgery
Current gold standard
Eligibility Criteria
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Inclusion Criteria
* High risk endometrial cancer
Exclusion Criteria
* Severe comorbidity, ASA\>3
* Unable to understand information
18 Years
75 Years
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Henrik Falconer
MD, PhD
Principal Investigators
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Henrik Falconer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Salehi S, Avall-Lundqvist E, Legerstam B, Carlson JW, Falconer H. Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial. Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.
Other Identifiers
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2013/361-31/1
Identifier Type: -
Identifier Source: org_study_id
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