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Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

Primary Purpose

Endometrial Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Robotic surgery
Abdominal surgery
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic surgery

Abdominal surgery

Arm Description

Experimental method, to be compared with standard care

Conventional open surgery (laparotomy)

Outcomes

Primary Outcome Measures

Number of harvested lymph nodes
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
Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
Lymphatic side-effects
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
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
All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.

Full Information

First Posted
May 2, 2013
Last Updated
March 5, 2018
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01847703
Brief Title
Robotic Versus Abdominal Surgery for Endometrial Cancer
Acronym
RASHEC
Official Title
Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic surgery
Arm Type
Experimental
Arm Description
Experimental method, to be compared with standard care
Arm Title
Abdominal surgery
Arm Type
Active Comparator
Arm Description
Conventional open surgery (laparotomy)
Intervention Type
Procedure
Intervention Name(s)
Robotic surgery
Intervention Description
Minimal invasive surgery performed with daVinci robotic system
Intervention Type
Procedure
Intervention Name(s)
Abdominal surgery
Intervention Description
Current gold standard
Primary Outcome Measure Information:
Title
Number of harvested lymph nodes
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Recurrence of cancer
Description
Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site
Time Frame
3 years
Title
Lymphatic side-effects
Description
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
Time Frame
2 years
Title
Quality of life
Description
All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery
Time Frame
2 years
Title
Healthcare cost
Description
All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Falconer, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28463759
Citation
Salehi S, Avall-Lundqvist E, Legerstam B, Carlson JW, Falconer H. Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial. Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.
Results Reference
derived

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Robotic Versus Abdominal Surgery for Endometrial Cancer

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