Kidney StonesNCT06746779
The Role of Preoperative Ureteral Diameter Measurements in Predicting Difficult Access During Retrograde Intrarenal Surgery: A Retrospective Analysis of 234 Patients
An observational study of Kidney Stones and Retrograde Intrarenal Surgery, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study investigates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (RIRS) in patients with kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Retrograde Intrarenal Surgery, Difficult Ureteral Access Prediction
- How many people
- 234 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basri Cakiroglu
Istanbul, 34768
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: Hisar Hospital Intercontinental
This study investigates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (RIRS) in patients with kidney stones. A retrospective analysis was conducted on 234 patients who underwent RIRS, evaluating factors such as preoperative ureteral diameters (measured at distal, iliac, and upper ureteral levels via CT scans), stone size, patient demographics, operation duration, and surgical success rates. The findings aim to determine whether ureteral diameter measurements can serve as reliable predictors for surgical challenges, ultimately improving preoperative planning and patient outcomes.
Read the 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.
- Keywords
- Retrospective analysis of 234 patients undergoing retrograde intrarenal surgery (RIRS).
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Preoperative Ureteral Diameter for Difficult Access During RIRS
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).
Measured: Intraoperative (assessed during the surgical procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
- Investigators
- Basri Cakiroglu, Principal investigator, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746779
- Sponsor's protocol ID
- 13.12.2024. 24-12
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hisar Hospital Intercontinental
- ClinicalTrials.gov ID
- NCT06746779
- Acronym / sponsor ID
- 13.12.2024. 24-12
- Keywords
- Retrospective analysis of 234 patients undergoing retrograde intrarenal surgery (RIRS).
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (RIRS) in patients with kidney stones. A retrospective analysis was conducted on 234 patients who underwent RIRS, evaluating factors such as preoperative ureteral diameters (measured at distal, iliac, and upper ureteral levels via CT scans), stone size, patient demographics, operation duration, and surgical success rates. The findings aim to determine whether ureteral diameter measurements can serve as reliable predictors for surgical challenges, ultimately improving preoperative planning and patient outcomes.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basri Cakiroglu principal investigator
Hisar Intercontinental Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones and Retrograde Intrarenal Surgery, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of Preoperative Ureteral Diameter for Difficult Access During RIRS (time frame: Intraoperative (assessed during the surgical procedure).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.