- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960149
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Araz Musaev, Dr
- Phone Number: +905364536276
- Email: msyv.araz@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with low-intermediate risk prostate cancer
Exclusion Criteria:
- Patients high risk prostate cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group using Indocyanine Green
Performing nerve-sparing robot-assisted laparoscopic radical prostatectomy by IV injecting of Indocyanine Green
|
Nerve-sparing robot-assisted laparoscopic radical prostatectomy using Indocyanine Green
Other Names:
|
Experimental: The Indocyanine Green -unused group
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
|
Nerve-sparing robot-assisted laparoscopic radical prostatectomy without the use of Indocyanine Green
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of erectile function.
Time Frame: 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). |
up to 12 months
|
Evaluation of surgical margin positivity
Time Frame: 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
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Araz Musaev, Ankara Universitry
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A01062021Z
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erectile Dysfunction Following Radical Prostatectomy
-
Federico II UniversityCompletedErectile Dysfunction Following Radical ProstatectomyItaly
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
St. Antonius HospitalNot yet recruitingErectile Dysfunction | Erectile Dysfunction Following Radical ProstatectomyNetherlands
-
Federal University of Health Science of Porto AlegreCompletedErectile Dysfunction Following Radical ProstatectomyBrazil
-
Dornier MedTech SystemsHospital Universitari de BellvitgeUnknown
-
Federico II UniversityCompletedErectile Dysfunction Following Radical ProstatectomyItaly
-
University Hospital of PatrasRecruitingErectile Dysfunction Following Radical ProstatectomyGreece
-
Kantonsspital Winterthur KSWTerminatedErectile Dysfunction Following Radical ProstatectomySwitzerland
-
Biozeus Biopharmaceutical S.A.Azidus Brasil Scientific Research and Development LtdaCompletedErectile Dysfunction | Prostate Cancer | Radical Prostatectomy | Erectile Dysfunction Following Radical ProstatectomyBrazil
-
Case Comprehensive Cancer CenterThe Cleveland Clinic; University Hospitals Cleveland Medical CenterTerminatedErectile Dysfunction | Prostate Cancer | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple ProstatectomyUnited States
Clinical Trials on using Indocyanine Green
-
Leiden University Medical CenterRecruitingFluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine GreenParagangliomaNetherlands
-
University of PennsylvaniaCompletedIschemic Stroke | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intracerebral Hemorrhage | Acute Anoxic EncephalopathyUnited States
-
Corporacion Parc TauliRecruitingAcute Cholecystitis | Bile Duct InjurySpain
-
Wei ChenEnrolling by invitation
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingOvarian Cancer | Adnexal MassUnited States
-
Shanghai University of Traditional Chinese MedicineUnknownRheumatoid Arthritis | Lymph Node Mass | Lymphatic Vessel; DilatationChina
-
Charles University, Czech RepublicNot yet recruitingPancreatic FistulaCzechia
-
Birmingham Women's and Children's NHS Foundation...Not yet recruitingTracheo-Esophageal Fistula With Atresia of EsophagusUnited Kingdom
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruitingSentinel Lymph NodeTurkey
-
NYU Langone HealthRecruitingRotator Cuff TearsUnited States