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The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EinsteinVision 3D visualization system | Device | Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system. |
| Measure | Description | Time Frame |
|---|---|---|
| Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.] | learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss [ml] | Intraoperatively | |
| Intraoperative blood transfusions [quantity] | Intraoperatively | |
| Postoperative blood transfusions [quantity] |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Klinikum Offenbach | Offenbach | 63069 | Germany | |||
| medius Klinik Ostfildern-Ruit |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Postoperatively |
| Intraoperative incidence of complications [percentage] | (e.g. bleedings, Trauma of ureter) | Intraoperatively |
| Postoperative incidence of complications [percentage] | (e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings) | During stay in Hospital (5-12 days postoperatively) |
| Surgeon's experience with different operation methods and application systems | using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In) | After first intervention for each hospital and after study completion, an average of 1 year later |
| Patient's quality of life | Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L The following dimensions are assessed:
| Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively |
| Operation time [min.] | Intraoperatively |
| Intraoperative usability of the device | using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable). The following dimensions are assessed:
| Intraoperatively |
| Incontinence after catheterization [percentage] | During stay in Hospital (5-12 days postoperatively) |
| Postoperative hospital stay [days] | During stay in Hospital (5-12 days postoperatively) |
| Return to erectile function [percentage] | 12 months |
| Return to continence function [percentage] | 12 months |
| Incontinence pads/pants per day [quantity] | 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively |
| Postoperative patient satisfaction | using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied) | 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively |
| Ostfildern |
| 73760 |
| Germany |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |