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Use of Indocyanine Green in Robotic Prostate Surgeries

Sponsor
Ankara University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960149
Collaborator
(none)
200
Enrollment
2
Arms
32
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Imaging of the vascular nerve bundle using Indocyanine Green

Condition or Disease Intervention/Treatment Phase
  • Drug: using Indocyanine Green
  • Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy
 Phase 4

Detailed Description

Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effect of Intraoperative Indocyanine Green Use on Erectile Function and Surgical Margin Positivity in Patients Undergoing Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Dec 3, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group using Indocyanine Green

Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green

Drug: using Indocyanine Green
Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green
Other Names:
  • IV Indocyanine Green injection

    		•
    Experimental: The Indocyanine Green -unused group

    Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

    Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy
    Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of erectile function. [up to 12 months]

      Evaluation of erectile function after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green.Evaluation of surgical margin positivity after Nerve Sparing Robot Assisted Laparoscopic Radical Prostatectomy with and without the application of Indocyanine Green. Both groups will evaluate their erectile function by completing the preoperative International Index of Erectile Function Every groups of participants will fill the International Index of Erectile Function -5 again after surgery in 3. -6. -9. -12 months. The possible scores for the International Index of Erectile Function- 5 range from 0 to 30, and Erectile disfonction is classified into five categories based on the scores: severe (0-10), moderate (11-16), mild to moderate (17-21), mild (22-25), and no erectile disfonction (26-30).

    2. Evaluation of surgical margin positivity [Up to 12 months]

      Postoperative surgical margin positivity will be compared in both groups according to the results of the postoperative pathology report. Surgical margin positivity in both groups will be evaluated as a percentage and it will be evaluated whether there is a significant difference between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with low-intermediate risk prostate cancer
    Exclusion Criteria:
    • Patients high risk prostate cancer

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Principal Investigator: Araz Musaev, Ankara Universitry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Araz Musaev, Principal İnvesitgator, Ankara University
    ClinicalTrials.gov Identifier:
    NCT05960149
    Other Study ID Numbers:
    • A01062021Z
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Araz Musaev, Principal İnvesitgator, Ankara University
    erectile dysfunction and indocyanine green
    radical prostatectomy and indocyanine green
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jul 25, 2023