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Completed

NCT Number: NCT02991794

Prostatectomies Using Einstein Vision® 3D

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sana Klinikum Offenbach, Offenbach, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EinsteinVision 3D visualization system

Device

Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.

Primary outcomes

  1. Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]

    Time frame: Intraoperatively

    learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system

Secondary outcomes

  1. Intraoperative blood loss [ml]

    Time frame: Intraoperatively

  2. Intraoperative blood transfusions [quantity]

    Time frame: Intraoperatively

  3. Postoperative blood transfusions [quantity]

    Time frame: Postoperatively

  4. Intraoperative incidence of complications [percentage]

    Time frame: Intraoperatively

    (e.g. bleedings, Trauma of ureter)

  5. Postoperative incidence of complications [percentage]

    Time frame: During stay in Hospital (5-12 days postoperatively)

    (e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)

  6. Surgeon's experience with different operation methods and application systems

    Time frame: 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)

  7. Patient's quality of life

    Time frame: 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

  8. Operation time [min.]

    Time frame: Intraoperatively

  9. Intraoperative usability of the device

    Time frame: 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

  10. Incontinence after catheterization [percentage]

    Time frame: During stay in Hospital (5-12 days postoperatively)

  11. Postoperative hospital stay [days]

    Time frame: During stay in Hospital (5-12 days postoperatively)

  12. Return to erectile function [percentage]

    Time frame: 12 months

  13. Return to continence function [percentage]

    Time frame: 12 months

  14. Incontinence pads/pants per day [quantity]

    Time frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively

  15. Postoperative patient satisfaction

    Time frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively

    using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: PROSTEVIS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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