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Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Minna Mäenpää, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01466777
First received: August 18, 2011
Last updated: October 8, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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

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

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   30 Years to 85 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466777

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

No publications provided

Responsible Party: Minna Mäenpää, Principal Investigator, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01466777     History of Changes
Other Study ID Numbers: R10081
Study First Received: August 18, 2011
Last Updated: October 8, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Keywords provided by 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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014