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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Evaluation of erectile function.
研究概览
简要总结
Imaging of the vascular nerve bundle using Indocyanine Green
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with low-intermediate risk prostate cancer
排除标准
- •Patients high risk prostate cancer
研究组 & 干预措施
Group using Indocyanine Green
Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green
干预措施: using Indocyanine Green (Drug)
The Indocyanine Green -unused group
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
干预措施: Nerve-sparing robot-assisted laparoscopic radical prostatectomy (Procedure)
结局指标
主要结局
Evaluation of erectile function.
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Araz Musaev
Principal İnvesitgator
Ankara University