Use of Indocyanine Green in Robotic Prostate Surgeries

Phase 4

Not yet recruiting

• Conditions: Prostate Cancer Adenocarcinoma; Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Procedure: Nerve-sparing robot-assisted laparoscopic radical prostatectomy; Drug: using Indocyanine Green

• Registration Number: NCT05960149
• Lead Sponsor: Ankara University

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

Study Timeline

• Study First Submitted: 2023-05-31
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Study Start: 2023-07-30
• Primary Completion: 2025-12-03
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Patients with low-intermediate risk prostate cancer

Exclusion Criteria

• Patients high risk prostate cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Indocyanine Green -unused group	Nerve-sparing robot-assisted laparoscopic radical prostatectomy	Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
Group using Indocyanine Green	using Indocyanine Green	Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green

Primary Outcome Measures

Name	Time	Method
Evaluation of erectile function.	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	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