NCT06746779

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

December 18, 2024

Last Update Submit

December 21, 2024

Conditions

Keywords

Retrospective analysis of 234 patients undergoing retrograde intrarenal surgery (RIRS).

Outcome Measures

Primary Outcomes (1)

  • 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).

    Intraoperative (assessed during the surgical procedure).

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basri Cakiroglu

Istanbul, 34768, Turkey (Türkiye)

Location

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Basri Cakiroglu

    Hisar Intercontinental Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 24, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 10, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations