Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

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: NCT01847703
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
Henrik Falconer, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Neoplasms Procedure: Robotic surgery Procedure: Abdominal surgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Study Start Date : April 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2017

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Recurrence of cancer [ Time Frame: 3 years ]
    Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site

  2. 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

  3. 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

  4. 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT01847703

Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Henrik Falconer, MD, PhD Karolinska Institutet

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Henrik Falconer, MD, PhD, Karolinska Institutet Identifier: NCT01847703     History of Changes
Other Study ID Numbers: 2013/361-31/1
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

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