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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01847703 |
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Date of registration:
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02/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Robotic Versus Abdominal Surgery for Endometrial Cancer
RASHEC |
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Scientific title:
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Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01847703 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Henrik Falconer, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-75 years of age
- High risk endometrial cancer
Exclusion Criteria:
- WHO performance>1
- Severe comorbidity, ASA>3
- Unable to understand information
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometrial Neoplasms
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Intervention(s)
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Procedure: Abdominal surgery
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Procedure: Robotic surgery
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Primary Outcome(s)
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Number of harvested lymph nodes
[Time Frame: 2 years]
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Secondary Outcome(s)
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Recurrence of cancer
[Time Frame: 3 years]
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Healthcare cost
[Time Frame: 2 years]
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Lymphatic side-effects
[Time Frame: 2 years]
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Quality of life
[Time Frame: 2 years]
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Secondary ID(s)
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2013/361-31/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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