Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

March 5, 2018 updated by: Henrik Falconer, Karolinska Institutet

Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).

Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)

Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-75 years of age
  • High risk endometrial cancer

Exclusion Criteria:

  • WHO performance>1
  • Severe comorbidity, ASA>3
  • Unable to understand information

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
Experimental: Robotic surgery
Experimental method, to be compared with standard care
Procedure: Robotic surgery
Minimal invasive surgery performed with daVinci robotic system
Active Comparator: Abdominal surgery
Conventional open surgery (laparotomy)
Procedure: Abdominal surgery
Current gold standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of harvested lymph nodes
Time Frame: 2 years
Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of cancer
Time Frame: 3 years
Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
3 years
Lymphatic side-effects
Time Frame: 2 years
Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up
2 years
Quality of life
Time Frame: 2 years
All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery
2 years
Healthcare cost
Time Frame: 2 years
All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
2 years

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Henrik Falconer, MD, PhD, Karolinska Institutet

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

April 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/361-31/1

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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