Brief Title
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
Official Title
Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
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
Study Type
Interventional
Primary Outcome
the operation time
Secondary Outcome
bleeding
Condition
Endometrium Cancer
Intervention
Traditional surgery type
Study Arms / Comparison Groups
traditional laparoscopic surgery type
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
November 2010
Completion Date
September 2019
Primary Completion Date
August 2019
Eligibility Criteria
Inclusion Criteria: - Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy - Gr 1 and 2 differentiation type Exclusion Criteria: - The operation cannot be made with an laparoscopy operation - Age more than 85 years or young under 30 years patient
Gender
Female
Ages
30 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT01466777
Organization ID
R10081
Responsible Party
Principal Investigator
Study Sponsor
Tampere University Hospital
Study Sponsor
, ,
Verification Date
June 2019