NCT01847703

Robotic Versus Abdominal Surgery for Endometrial Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Robotic surgery	Minimal invasive surgery performed with daVinci robotic system
PROCEDURE	Abdominal surgery	Current gold standard

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2013-05-07
• Last updated: 2018-03-06

Locations

1 site across 1 country: Sweden