Spots Global Cancer Trial Database for Robotic Versus Abdominal Surgery for Endometrial Cancer

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Trial Identification

Brief Title: Robotic Versus Abdominal Surgery for Endometrial Cancer

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

Study ID: NCT01847703

Conditions

Endometrial Neoplasms

Interventions

Robotic surgery

Abdominal surgery

Study Description

Brief Summary: 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.

Detailed 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.