GYN Disorders
Conditions
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
Interventions
DEVICELaparoscopy
Laparoscopic surgery
DEVICERobotic-assisted surgery
Robotic-assisted surgery
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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 Key
Exclusion criteria
* Life expectancy for less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications of medical interest | 90 days | Describe complication of medical interest |
| Describe treatment decision | Enrollment Completion | Describe treatment decision for the procedure of choice |
| Describe patient outcome | 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 | 12 Months | Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Impact per patient reported questionnaires | 12 Months | Describe Quality of Life impact as assessed via patient reported questionnaires; changes in quality of life questionnaires scores between baseline and up to follow-up 12 months will be assessed (EQ-5D-5L on mobility, self-care, usual activities, pain/discomfort, anxiety/depression) |
| Describe the impact of surgeon experience on outcome | 12 Months | Describe the impact of surgeon experience on outcome; individual surgeon experience will be collected (self-reported by surgeon) and linked to every performed procedure; descriptive assessment if the reported surgeon experience has an impact on the outcome, e.g. number of reported complications. As surgeon experience, the number of performed procedures per indication and technique (robotic-assisted surgery or laparoscopy will be collected), as well as the overall years the surgeon is performing surgeries. |
| Describe the performance and use of Intuitive instruments | 12 Months | Describe the performance and use of Intuitive instruments; information on any device failure or device deficiency will be collected and descriptively assessed |
| Describe the performance and use of Intuitive systems | 12 Months | Describe the performance and use of Intuitive systems; information on any device failure or device deficiency will be collected and descriptively assessed |
Outcome results
None listed