Spots Global Cancer Trial Database for Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

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Trial Identification

Brief Title: Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

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

Study ID: NCT01466777

Conditions

Endometrium Cancer

Interventions

Traditional surgery type

Robotic assisted laparoscopic surgery

Study Description

Brief 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

Detailed Description: