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Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

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. Identifier: NCT01466777
Recruitment Status : Active, not recruiting
First Posted : November 8, 2011
Last Update Posted : June 6, 2019
Information provided by (Responsible Party):
Minna Mäenpää, Tampere University Hospital

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

Condition or disease Intervention/treatment Phase
Endometrium Cancer Procedure: Traditional surgery type Procedure: Robotic assisted laparoscopic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : November 2010
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. bleeding [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
  2. Number of participants with adverse events [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
  3. Pain [ Time Frame: Duration of hospital stay, an expected average of 5 weeks ]
    visual analogue scale

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01466777

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Minna Mäenpää, Principal Investigator, Tampere University Hospital Identifier: NCT01466777     History of Changes
Other Study ID Numbers: R10081
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Keywords provided by Minna Mäenpää, Tampere University Hospital:
Endometrium cancer
Robotic-assisted laparoscopy
Traditional laparoscopy
Laparoscopic surgery
Operation time
Pelvic lymph node
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female