Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criteria

High risk endometrial cancer
18-75 years of age
High risk endometrial cancer
18-75 years of age

Exclusion Criteria

WHO performance>1
Unable to understand information
Severe comorbidity, ASA>3
WHO performance>1
Unable to understand information
Severe comorbidity, ASA>3

Summary

Conditions
Endometrial Neoplasms
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Only females

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...

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

High risk endometrial cancer
18-75 years of age
High risk endometrial cancer
18-75 years of age

Exclusion Criteria

WHO performance>1
Unable to understand information
Severe comorbidity, ASA>3
WHO performance>1
Unable to understand information
Severe comorbidity, ASA>3

Locations

Stockholm, 17176
Stockholm, 17176

Tracking Information

NCT #
NCT01847703
Collaborators
Not Provided
Investigators
  • Principal Investigator: Henrik Falconer, MD, PhD Karolinska Institutet
  • Henrik Falconer, MD, PhD Karolinska Institutet