This trial is active, not recruiting.

Condition endometrial neoplasms
Treatments robotic surgery, abdominal surgery
Sponsor Karolinska Institutet
Start date April 2013
End date July 2016
Trial size 120 participants
Trial identifier NCT01847703, 2013/361-31/1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Experimental method, to be compared with standard care
robotic surgery
Minimal invasive surgery performed with daVinci robotic system
(Active Comparator)
Conventional open surgery (laparotomy)
abdominal surgery
Current gold standard

Primary Outcomes

Number of harvested lymph nodes
time frame: 2 years

Secondary Outcomes

Recurrence of cancer
time frame: 3 years
Lymphatic side-effects
time frame: 2 years
Quality of life
time frame: 2 years
Healthcare cost
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 75 years old.

Inclusion Criteria: - 18-75 years of age - High risk endometrial cancer Exclusion Criteria: - WHO performance>1 - Severe comorbidity, ASA>3 - Unable to understand information

Additional Information

Official title Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Principal investigator Henrik Falconer, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.