Robotic Versus Abdominal Surgery for Endometrial Cancer

Endometrial Neoplasms Clinical Trial

— RASHEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847703
• Other study ID #: 2013/361-31/1
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: March 5, 2018
• Start date: April 2013
• Est. completion date: July 2017

Study information

• Verified date: March 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years of age

• High risk endometrial cancer

Exclusion Criteria:

• WHO performance>1

• Severe comorbidity, ASA>3

• Unable to understand information

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Procedure:
• Robotic surgery
Minimal invasive surgery performed with daVinci robotic system
• Abdominal surgery
Current gold standard

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	Recurrence of cancer	Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site	3 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	Healthcare cost	All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.	2 years