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Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

18 Years
75 Years
Open (Enrolling)
Endometrial Neoplasms

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Trial Information

Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

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.

Inclusion Criteria:

- 18-75 years of age

- High risk endometrial cancer

Exclusion Criteria:

- WHO performance>1

- Severe comorbidity, ASA>3

- Unable to understand information

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of harvested lymph nodes

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Henrik Falconer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institutet


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

April 2013

Completion Date:

April 2018

Related Keywords:

  • Endometrial Neoplasms
  • Neoplasms
  • Endometrial Neoplasms
  • Adenoma