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
Overview
- Phase
- Phase 4
- Intervention
- using Indocyanine Green
- Conditions
- Prostate Cancer Adenocarcinoma
- Sponsor
- Ankara University
- Enrollment
- 200
- Primary Endpoint
- Evaluation of erectile function.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Imaging of the vascular nerve bundle using Indocyanine Green
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
Investigators
Araz Musaev
Principal İnvesitgator
Ankara University
Eligibility Criteria
Inclusion Criteria
- •Patients with low-intermediate risk prostate cancer
Exclusion Criteria
- •Patients high risk prostate cancer
Arms & Interventions
Group using Indocyanine Green
Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green
Intervention: using Indocyanine Green
The Indocyanine Green -unused group
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
Intervention: Nerve-sparing robot-assisted laparoscopic radical prostatectomy
Outcomes
Primary Outcomes
Evaluation of erectile function.
Time Frame: 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).
Evaluation of surgical margin positivity
Time Frame: 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