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Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Henrik Falconer, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01847703
First received: May 2, 2013
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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 Intervention
Endometrial Neoplasms Procedure: Robotic surgery Procedure: Abdominal surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

Further study details as provided by Henrik Falconer, Karolinska Institutet:

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

  • 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

  • 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

  • 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.


Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: May 2018
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • WHO performance>1
  • Severe comorbidity, ASA>3
  • Unable to understand information
  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: NCT01847703

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

Responsible Party: Henrik Falconer, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01847703     History of Changes
Other Study ID Numbers: 2013/361-31/1
Study First Received: May 2, 2013
Last Updated: August 29, 2016

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

ClinicalTrials.gov processed this record on June 26, 2017