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Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Tampere University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Minna Mäenpää, Tampere University Hospital Identifier:
First received: August 18, 2011
Last updated: March 23, 2016
Last verified: May 2015

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

Condition Intervention
Endometrium Cancer
Procedure: Traditional surgery type
Procedure: Robotic assisted laparoscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

Resource links provided by NLM:

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • the operation time [ Time Frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours ]

Secondary Outcome Measures:
  • bleeding [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
  • Number of participants with adverse events [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
  • Pain [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
    visual analogue scale

  • pelvic lymph node volumes [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: traditional laparoscopic surgery type Procedure: Traditional surgery type
Traditional laparoscopic surgery for endometrial cancer
Experimental: Robotic assisted operation type Procedure: Robotic assisted laparoscopic surgery
Robotic assisted laparoscopic surgery for endometrial cancer


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01466777

Tampere University Hospital
Tampere, P.O.Box 2000, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

Responsible Party: Minna Mäenpää, Principal Investigator, Tampere University Hospital Identifier: NCT01466777     History of Changes
Other Study ID Numbers: R10081
Study First Received: August 18, 2011
Last Updated: March 23, 2016

Keywords provided by Tampere University Hospital:
Endometrium cancer
Robotic-assisted laparoscopy
Traditional laparoscopy
Laparoscopic surgery
Operation time
Pelvic lymph node

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on May 22, 2017