Robotic Versus Abdominal Surgery for Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Neoplasms
• Interventions: Procedure: Abdominal surgery; Procedure: Robotic surgery

• Registration Number: NCT01847703
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal surgery	Abdominal surgery	Conventional open surgery (laparotomy)
Robotic surgery	Robotic surgery	Experimental method, to be compared with standard care

Primary Outcome Measures

Name	Time	Method
Number of harvested lymph nodes	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

Name	Time	Method
Lymphatic side-effects	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	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	2 years	All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.
Recurrence of cancer	3 years	Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden