NCT01466777

Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients. The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account. The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer. Secondary endpoints include: 1. bleeding 2. complications 3. conversions 4. number of pelvic lymph nodes

Conditions

• Endometrium Cancer

Interventions

Type	Name	Description
PROCEDURE	Traditional surgery type	Traditional laparoscopic surgery for endometrial cancer
PROCEDURE	Robotic assisted laparoscopic surgery	Robotic assisted laparoscopic surgery for endometrial cancer

Timeline

• Start date: 2010-11-01
• Primary completion: 2019-08-01
• Completion: 2019-09-01
• First posted: 2011-11-08
• Last updated: 2019-06-06

Locations

1 site across 1 country: Finland