Prostate Carcinoma
Conditions
Keywords
prostatectomy, laparoscopy, 3D visualization, learning curve, anastomosis
Brief summary
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.
Interventions
DEVICEEinsteinVision 3D visualization system
Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.] | Intraoperatively | learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss [ml] | Intraoperatively | — |
| Intraoperative blood transfusions [quantity] | Intraoperatively | — |
| Postoperative blood transfusions [quantity] | Postoperatively | — |
| Intraoperative incidence of complications [percentage] | Intraoperatively | (e.g. bleedings, Trauma of ureter) |
| Postoperative incidence of complications [percentage] | During stay in Hospital (5-12 days postoperatively) | (e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings) |
| Surgeon's experience with different operation methods and application systems | After first intervention for each hospital and after study completion, an average of 1 year later | using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In) |
| Operation time [min.] | Intraoperatively | — |
| Patient's quality of life | Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively | 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 |
| 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 | 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively | using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied) |
| Intraoperative usability of the device | Intraoperatively | 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 |
Countries
Germany
Outcome results
None listed