ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- GYN Disorders
- Sponsor
- Intuitive Surgical
- Primary Endpoint
- Describe treatment decision
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy
Detailed Description
A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is willing to participate and to comply with the study procedures
- •Patient present with gynecological disease that may be treated with surgical intervention
Exclusion Criteria
- •Life expectancy for less than 1 year
Outcomes
Primary Outcomes
Describe treatment decision
Time Frame: Enrollment Completion
Describe treatment decision for the procedure of choice
Describe patient outcome
Time Frame: 12 Months
Describe patient outcome from robotic-assisted surgery and conventional laparoscopy by using physiological parameter such as relief or improvement of symptoms, number of complications or number of re-operations and changes in the patient reported quality of life (EQ-5D-5L) between baseline and FU at 12 Months (changes in the score)
Describe impact of patient factors on outcome
Time Frame: 12 Months
Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities
Complications of medical interest
Time Frame: 90 days
Describe complication of medical interest
Secondary Outcomes
- Quality of Life Impact per patient reported questionnaires(12 Months)
- Describe the impact of surgeon experience on outcome(12 Months)
- Describe the performance and use of Intuitive systems(12 Months)
- Describe the performance and use of Intuitive instruments(12 Months)