Clinical Trial: Robotic Versus Abdominal Surgery for Endometrial Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Karolinska Institutet

Current Primary Outcome: 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


Original Primary Outcome: Number of harvested lymph nodes [ Time Frame: 1 year ]

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


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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: 1 year ]
    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: 1 year ]
    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: 1 year ]
    All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.


Information By: Karolinska Institutet

Dates:
Date Received: May 2, 2013
Date Started: April 2013
Date Completion: May 2018
Last Updated: August 29, 2016
Last Verified: August 2016