Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

June 5, 2019 updated by: Minna Mäenpää, Tampere University Hospital

Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • P.O.Box 2000
      • Tampere, P.O.Box 2000, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the operation time
Time Frame: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding
Time Frame: Duration of hospital stay, an expected average of 5 weeks
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
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
Duration of hospital stay, an expected average of 5 weeks
pelvic lymph node volumes
Time Frame: Duration of hospital stay, an expected average of 5 weeks
Duration of hospital stay, an expected average of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R10081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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