Robotic Versus Abdominal Surgery for Endometrial Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Neoplasms

Intervention / Treatment
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* Procedure: Robotic surgery
* Procedure: Abdominal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years of age High risk endometrial cancer Exclusion Criteria: WHO performance>1 Severe comorbidity, ASA>3 Unable to understand information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery<br>Experimental method, to be compared with standard care | Procedure: Robotic surgery<br>* Minimal invasive surgery performed with daVinci robotic system<br>|
| Active Comparator: Abdominal surgery<br>Conventional open surgery (laparotomy) | Procedure: Abdominal surgery<br>* Current gold standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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