ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy

Study Overview
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Brief Summary
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Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy

Detailed Description
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A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

Official Title
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ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

Conditions
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GYN Disorders

Intervention / Treatment
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* Device: Laparoscopy
* Device: Robotic-assisted surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidemiological Section<br>Consecutive enrollment of patients with indications of interest | |
| Observational Section<br>Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery | Device: Laparoscopy<br>* Laparoscopic surgery<br>Device: Robotic-assisted surgery<br>* Robotic-assisted surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe treatment decision | Describe treatment decision for the procedure of choice | Enrollment Completion | 
| Describe patient outcome | 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) | 12 Months | 
| Describe impact of patient factors on outcome | Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities | 12 Months | 
| Complications of medical interest | Describe complication of medical interest | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Impact per patient reported questionnaires | 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) | 12 Months | 
| Describe the impact of surgeon experience on outcome | 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. | 12 Months | 
| Describe the performance and use of Intuitive instruments | Describe the performance and use of Intuitive instruments; information on any device failure or device deficiency will be collected and descriptively assessed | 12 Months | 
| Describe the performance and use of Intuitive systems | Describe the performance and use of Intuitive systems; information on any device failure or device deficiency will be collected and descriptively assessed | 12 Months |