- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06746779
The Role of Preoperative Ureteral Diameter Measurements in Predicting Difficult Access During Retrograde Intrarenal Surgery: A Retrospective Analysis of 234 Patients
Hisar Hospital Intercontinental
Study Overview
Status
Detailed Description
This retrospective study evaluates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (RIRS) in patients with kidney stones. A total of 234 patients who underwent RIRS were included in the analysis. Preoperative computed tomography (CT) scans were used to measure ureteral diameters at three levels: distal ureter, iliac ureter, and upper ureter. The relationship between ureteral diameter and intraoperative access difficulty was assessed.
The study also analyzed patient demographics (age, gender, BMI), stone characteristics (size, location), operative parameters (duration, access attempts), and outcomes (surgical success and complication rates). Difficult access during RIRS was defined based on the number of attempts required to achieve successful ureteral access, need for secondary procedures, or inability to complete the planned surgery.
The primary aim was to determine whether preoperative ureteral diameter measurements can serve as predictive markers for challenging surgical access. Secondary objectives included identifying other patient or stone-related factors contributing to access difficulty and evaluating their impact on surgical outcomes. The findings may assist clinicians in preoperative planning, improving patient selection for RIRS, and optimizing intraoperative strategies to minimize complications and enhance procedural success rates.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34768
- Hisar Intercontinental Hospital
-
Istanbul, Turkey, 34768
- Basri Cakiroglu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of adult patients (aged 18 years and older) who underwent retrograde intrarenal surgery (RIRS) for the management of kidney stones at a tertiary care center. Patients included in the study were evaluated retrospectively, with data obtained from their medical records, including preoperative imaging, intraoperative findings, and postoperative outcomes.
The population represents a diverse group in terms of age, gender, body mass index (BMI), and stone characteristics (e.g., size, location). Patients with sufficient preoperative imaging data and complete surgical records were included to ensure accurate analysis of ureteral diameter measurements and their relationship to surgical outcomes.
Description
Inclusion Criteria:
Patients aged 18 years or older. Diagnosed with kidney stones (nephrolithiasis) requiring surgical intervention. Underwent retrograde intrarenal surgery (RIRS). Available preoperative CT scans for ureteral diameter measurements. Complete medical records, including demographic, clinical, and surgical data.
Exclusion Criteria:
History of open or laparoscopic renal surgery. Presence of ureteral strictures or congenital anomalies. Patients with incomplete or missing medical records. Active urinary tract infection at the time of surgery. Pregnant or lactating individuals.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Easy Access Group
Patients with successful ureteral access on the first attempt during retrograde intrarenal surgery (RIRS).
|
|
Difficult Access Group
Patients requiring multiple attempts for ureteral access, alternative procedures, or cases where the planned surgery could not be completed due to access issues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Value of Preoperative Ureteral Diameter for Difficult Access During RIRS
Time Frame: Intraoperative (assessed during the surgical procedure).
|
Evaluate the correlation between preoperative ureteral diameters (measured at distal, iliac, and upper ureteral levels via CT imaging) and the difficulty of achieving ureteral access during retrograde intrarenal surgery (RIRS).
|
Intraoperative (assessed during the surgical procedure).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Basri Cakiroglu, Hisar Intercontinental Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 13.12.2024. 24-12
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 Kidney Stones
-
Calyxo, Inc.Not yet recruitingUrolithiasis | Kidney Stones | Renal Stones | Stones, Kidney
-
Indiana Kidney Stone InstituteUniversity of Washington; VA Puget Sound Health Care SystemCompleted
-
Omeros CorporationCompletedUrinary Calculi | Renal Calculi | Kidney Stones | Urinary Stones | Urinary Tract StonesUnited States
-
Mayo ClinicCompletedKidney Calculi | Nephrolithiasis | Kidney Stones | Renal StonesUnited States, Canada
-
Calyxo, Inc.RecruitingUrolithiasis | Kidney Stones | Renal Stones | Stones, KidneyUnited States
-
United States Naval Medical Center, San DiegoUnknown
-
AdventHealthNot yet recruitingKidney Calculi | Kidney Stones | Renal Stone Disease | Refractory Kidney StonesUnited States
-
University of British ColumbiaPercutaneous Systems, Inc.Completed
-
Robert SworWilliam Beaumont HospitalsCompletedKidney Stones | Ureteral StonesUnited States