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Overall re-assessment of study design
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Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy
A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidemiological Section | Consecutive enrollment of patients with indications of interest | ||
| Observational Section | Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy | Device | Laparoscopic surgery |
| |
| Robotic-assisted surgery |
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients present with gynecological disease that may be treated by surgical intervention
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| Name | Affiliation | Role |
|---|---|---|
| Ingolf Juhasz-Böss, Prof. Dr. | Universitätsklinikum Freiburg, Germany | Principal Investigator |
| Vincent Lavoué, Prof. Dr. | CHU de Rennes, France | Principal Investigator |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Device |
Robotic-assisted surgery |
|
| 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 |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D025321 | Surgery, Computer-Assisted |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |