Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

Karolinska Institute

Status: Completed

Conditions: Endometrial Neoplasms

Treatments: Procedure: Abdominal surgery; Procedure: Robotic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01847703

2013/361-31/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Robotic surgery

Experimental group

Description:

Experimental method, to be compared with standard care

Treatment:

Procedure: Robotic surgery

Abdominal surgery

Active Comparator group

Description:

Conventional open surgery (laparotomy)

Treatment:

Procedure: Abdominal surgery