Use of Indocyanine Green in Robotic Prostate Surgeries

Phase 4Not Yet RecruitingNCT05960149

Ankara University200 enrolled

Overview

Imaging of the vascular nerve bundle using Indocyanine Green

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Prostate Cancer Adenocarcinoma Erectile Dysfunction Following Radical Prostatectomy

Interventions

using Indocyanine GreenDRUG

Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green

Nerve-sparing robot-assisted laparoscopic radical prostatectomyPROCEDURE

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

Eligibility

Sex: MALEMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: Up to 12 months

Central Contacts

Araz Musaev, Dr

CONTACT

+905364536276 msyv.araz@gmail.com

Data from ClinicalTrials.gov

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