GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Study Overview
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Brief Summary
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GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications Generate real-world evidence in the use of the da Vinci Xi/X Surgical Systems for gynecological indications within the German health care system.

Detailed Description
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A prospective, non-interventional, multi-center, post market clinical study.

Official Title
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GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study

Conditions
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GYN Disorders

Intervention / Treatment
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* Device: Robotic-assisted surgery (da Vinci)
* Device: Non-da Vinci Surgery


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Woman with 18 years of age or older Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent Patient is a candidate for a gynecological procedure to be performed with the Intuitive Surgical System Key Exclusion Criteria: Life expectancy of less than 1 year Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women Current participation in a clinical study, if not pre-approved by Intuitive Individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation

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 |
| --- | --- |
| da Vinci Patients<br>Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery | Device: Robotic-assisted surgery (da Vinci)<br>* Robotic-assisted surgery (da Vinci)<br>|
| Epidemiological Data Audit<br>Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery | Device: Non-da Vinci Surgery<br>* Non-da Vinci Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the treatment decision as reported by the treating physician | Characterize the treatment decision per data provided by the treating physician (within the study database) including the rationale given for the treatment decision (e.g., age of the patient or co-morbidity); number of treatment decisions, e.g., for surgical therapy (open surgery or minimal-invasive therapy), watchful waiting, or treatment with medication will be described; descriptive analysis will be performed | 30 days | 
| Describe the number of patient-reported outcomes up to 12 months | Describe the patient-reported outcomes up to 12 months; descriptive analysis will be performed on the data directly reported via the patients (patient questionnaires); information included are number of complications, re-hospitalizations, re-operations, disease recurrence, disease remission, new disease diagnosis and pain status including pain medication | 12 months | 
| Number of complications related to the surgery up to 30 days | Describe the number of complications related to the surgery up to 30 days; adverse events as documented during the first 30 days will be classified as four different levels of causality to the surgery (not related, possible, probable and causal relationship). Descriptive analysis will be performed. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the impact of patient characteristics on surgery | Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage) | 30 days | 
| Investigate the impact of patient characteristics on clinical outcome | Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation) | 30 days | 
| Investigate the impact of patient characteristics on complications | Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery) | 30 days | 
| Describe the impact from surgery to the patient's quality of life and function | Describe the impact from surgery to the patient's quality of life and function by comparing the baseline quality of life and functional status with the post-operative status (post-operative day 1-3, 30 days, 90 days, 6 months and 12 months) | 12 months | 
| Describe the number of Intuitive instruments used per procedure and patient characteristics | Describe the number of Intuitive instruments used per procedure and patient characteristics; descriptive analysis will be performed on the number of instruments used per specific procedure and patient | 30 days | 
| Describe the number of disease recurrence and re-operation at final patient follow-up | Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed | 12 months | 
| Describe the number of conversion per procedure and patient characteristics | Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed | 30 days | 
| Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon) | Describe the impact of surgeon experience on surgical times, descriptive analysis will be performed on the surgical times (duration of surgery) per treating surgeon | 30 days | 
| Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon) | Describe the impact of surgeon experience on clinical outcome; descriptive analysis will be performed, e.g., on number of re-operation or re-hospitalization per treating surgeon | 30 days | 
| Describe the impact of surgeon experience on complications (number of events per surgeon) | Describe the impact of surgeon experience on complications; descriptive analysis will be performed on number of adverse events per treating surgeon | 30 days |