PROSTEVIS: Prostatectomies Using Einstein Vision® 3D

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02991794

Collaborator

(none)

156

Enrollment

Locations

41.6

Actual Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Carcinoma	Device: EinsteinVision 3D visualization system

Study Design

Study Type:

Observational

Actual Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 19, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Nov 6, 2020

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)
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
Operation time [min.] [Intraoperatively]
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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