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
Imaging of the vascular nerve bundle using Indocyanine Green
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
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 |
Status | Clinical Trial | Phase | |
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