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NCT05960149 Clinical Trial

Use of Indocyanine Green in Robotic Prostate Surgeries

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05960149
Other study ID # A01062021Z
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 30, 2023
Est. completion date March 31, 2026

Study information
Verified date July 2023
Source Ankara University
Contact Araz Musaev, Dr
Phone +905364536276
Email msyv.araz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Imaging of the vascular nerve bundle using Indocyanine Green

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date March 31, 2026
Est. primary completion date December 3, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A to 75 Years
Eligibility Inclusion Criteria: - Patients with low-intermediate risk prostate cancer Exclusion Criteria: - Patients high risk prostate cancer

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of erectile function. 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).		 up to 12 months
Primary Evaluation of surgical margin positivity 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 Up to 12 months
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