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.
Study Type
OBSERVATIONAL
Enrollment
156
Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.
Sana Klinikum Offenbach
Offenbach, Germany
medius Klinik Ostfildern-Ruit
Ostfildern, Germany
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
Time frame: Intraoperatively
Intraoperative blood loss [ml]
Time frame: Intraoperatively
Intraoperative blood transfusions [quantity]
Time frame: Intraoperatively
Postoperative blood transfusions [quantity]
Time frame: Postoperatively
Intraoperative incidence of complications [percentage]
(e.g. bleedings, Trauma of ureter)
Time frame: Intraoperatively
Postoperative incidence of complications [percentage]
(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)
Time frame: 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)
Time frame: 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
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Time frame: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Operation time [min.]
Time frame: 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
Time frame: Intraoperatively
Incontinence after catheterization [percentage]
Time frame: During stay in Hospital (5-12 days postoperatively)
Postoperative hospital stay [days]
Time frame: During stay in Hospital (5-12 days postoperatively)
Return to erectile function [percentage]
Time frame: 12 months
Return to continence function [percentage]
Time frame: 12 months
Incontinence pads/pants per day [quantity]
Time frame: 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)
Time frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively