Prostatectomies Using Einstein Vision® 3D

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Device: EinsteinVision 3D visualization system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision® Written informed consent Age ≥ 18 years Exclusion Criteria: Previous TURP (= transurethral resection of the prostate) Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum) BMI > 35 kg/m² Participation in another clinical study Representation by a legal guardian or under involuntary commitment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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

| Intervention/Treatment |
| --- |
|Device: EinsteinVision 3D visualization system|Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss [ml] |  | Intraoperatively | 
| Intraoperative blood transfusions [quantity] |  | Intraoperatively | 
| Postoperative blood transfusions [quantity] |  | 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: Mobility Self-care Usual activities Pain / discomfort Anxiety / depression Health | 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: Control Expenditure of energy Image quality Overall satisfaction | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatectomy, laparoscopy, 3D visualization, learning curve, anastomosis