Clinical trial NCT02991794: Prostatectomies Using Einstein Vision® 3D
Official title: Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Carcinoma
Keywords: prostatectomy
laparoscopy
3D visualization
learning curve
anastomosis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 156
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]
timeFrame: Intraoperatively
Secondary outcomes:
measure: Intraoperative blood loss [ml]
timeFrame: Intraoperatively
measure: Intraoperative blood transfusions [quantity]
timeFrame: Intraoperatively
measure: Postoperative blood transfusions [quantity]
timeFrame: Postoperatively
measure: Intraoperative incidence of complications [percentage]
timeFrame: Intraoperatively
measure: Postoperative incidence of complications [percentage]
timeFrame: During stay in Hospital (5-12 days postoperatively)
measure: Surgeon's experience with different operation methods and application systems
timeFrame: After first intervention for each hospital and after study completion, an average of 1 year later
measure: Patient's quality of life
timeFrame: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
measure: Operation time [min.]
timeFrame: Intraoperatively
measure: Intraoperative usability of the device
timeFrame: Intraoperatively
measure: Incontinence after catheterization [percentage]
timeFrame: During stay in Hospital (5-12 days postoperatively)
measure: Postoperative hospital stay [days]
timeFrame: During stay in Hospital (5-12 days postoperatively)
measure: Return to erectile function [percentage]
timeFrame: 12 months
measure: Return to continence function [percentage]
timeFrame: 12 months
measure: Incontinence pads/pants per day [quantity]
timeFrame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
measure: Postoperative patient satisfaction
timeFrame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Ostfildern
country: Germany
facility: medius Klinik Ostfildern-Ruit
Study officials:
References: