- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06797466
Three Dimensional Virtual Reconstruction (3D) in Percutaneous Nephrolithotomy
May 8, 2025 updated by: Bedreddin Kalyenci, Adiyaman University
Investigation of the Effect of Three Dimensional Virtual Reconstruction (3D) on Percutaneous Nephrolithotomy Learning Curve in Specialist Training
The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bedreddin Kalyenci, Doctor
- Phone Number: +905554859583
- Email: bedreddin84@windowslive.com
Study Locations
-
-
-
Adıyaman, Turkey
- Recruiting
- Adıyaman University
-
Contact:
- ADIYAMAN EDUCATION AND RESEARCH HOSPITAL
- Phone Number: +90 416 216 10 15
- Email: adiyamaneah1@saglik.gov.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with kidney stones larger than 2 cm and those with PCNL indication.
Exclusion Criteria:
- Patients with missing CT images, missing clinical information, or inaccessible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3D imaging technique on the PCNL
|
Establishing a percutaneous access route for the stone is the first and most important step in PCNL surgery.
Choosing the perfect route, position and direction largely depends on surgical experience and the ability to understand renal/peri-renal anatomy.
In general, a good CT scan of the abdomen and pelvis and an experienced surgeon are sufficient, but this requires significant time in the learning curve.
The aim of our study is to investigate the effect of 3D imaging technique on the PCNL learning curve in specialist training.
|
|
No Intervention: standard PCNL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with perioperative Bleeding.
Time Frame: immediately after the intervention/procedure/surgery
|
immediately after the intervention/procedure/surgery
|
|
Number of Participants with stone free
Time Frame: 1 month after the intervention/procedure/surgery
|
1 month after the intervention/procedure/surgery
|
|
leng of the hospital stay
Time Frame: immediately after the intervention/procedure/surgery
|
immediately after the intervention/procedure/surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with Complication
Time Frame: immediately after the intervention/procedure/surgery
|
immediately after the intervention/procedure/surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2025
Primary Completion (Actual)
January 21, 2025
Study Completion (Estimated)
October 31, 2025
Study Registration Dates
First Submitted
January 21, 2025
First Submitted That Met QC Criteria
January 27, 2025
First Posted (Actual)
January 28, 2025
Study Record Updates
Last Update Posted (Actual)
May 9, 2025
Last Update Submitted That Met QC Criteria
May 8, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRÜ/24.21.44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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