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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 Minna Mäenpää, Tampere University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466777
First Posted: November 8, 2011
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Minna Mäenpää, Tampere University Hospital
  Purpose

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: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

Further study details as provided by Minna Mäenpää, 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466777


Locations
Finland
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
ClinicalTrials.gov Identifier: NCT01466777     History of Changes
Other Study ID Numbers: R10081
First Submitted: August 18, 2011
First Posted: November 8, 2011
Last Update Posted: March 24, 2016
Last Verified: May 2015

Keywords provided by Minna Mäenpää, Tampere University Hospital:
Endometrium cancer
Robotic-assisted laparoscopy
Traditional laparoscopy
Laparoscopic surgery
Treatment
Operation time
Bleeding
Complications
Conversions
Pelvic lymph node

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female