Use of Indocyanine Green in Robotic Prostate Surgeries

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05960149

Enrollment

200

Registered

2023-07-25

Start date

2023-07-30

Completion date

2026-03-31

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer Adenocarcinoma

Keywords

erectile dysfunction and indocyanine green, radical prostatectomy and indocyanine green

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

Interventions

DRUGusing Indocyanine Green

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

PROCEDURENerve-sparing robot-assisted laparoscopic radical prostatectomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

No minimum to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients with low-intermediate risk prostate cancer

Exclusion criteria

* Patients high risk prostate cancer

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactAraz Musaev, Dr

msyv.araz@gmail.com+905364536276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026