Use of Indocyanine Green in Robotic Prostate Surgeries

Study Overview
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Brief Summary
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Imaging of the vascular nerve bundle using Indocyanine Green

Detailed Description
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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

Official Title
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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

Conditions
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Prostate Cancer Adenocarcinoma, Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Drug: using Indocyanine Green
* Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with low-intermediate risk prostate cancer Exclusion Criteria: Patients high risk prostate cancer

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group using Indocyanine Green<br>Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green | Drug: using Indocyanine Green<br>* Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green<br>* Other names: IV Indocyanine Green injection;|
| Experimental: The Indocyanine Green -unused group<br>Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green | Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy<br>* Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green