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Trial Title:
Use of Indocyanine Green in Robotic Prostate Surgeries
NCT ID:
NCT05960149
Condition:
Prostate Cancer Adenocarcinoma
Erectile Dysfunction Following Radical Prostatectomy
Conditions: Official terms:
Erectile Dysfunction
Conditions: Keywords:
erectile dysfunction and indocyanine green
radical prostatectomy and indocyanine green
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
using Indocyanine Green
Description:
Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green
Arm group label:
Group using Indocyanine Green
Other name:
IV Indocyanine Green injection
Intervention type:
Procedure
Intervention name:
Nerve-sparing robot-assisted laparoscopic radical prostatectomy
Description:
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of
Indocyanine Green
Arm group label:
The Indocyanine Green -unused group
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with low-intermediate risk prostate cancer
Exclusion Criteria:
- Patients high risk prostate cancer
Gender:
Male
Minimum age:
N/A
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 30, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Ankara University
Agency class:
Other
Source:
Ankara University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05960149