Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi

May 4, 2023 updated by: islam mohamed abou bakr mansour, Menoufia University
To predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Although flexible ureteroscopy has been in use for decades, neither the European Association of Urology (EAU) nor the American Urological association (AUA), in their clinical guidelines, recommends flexible ureteroscopy (FURS) as a first-line procedural treatment for renal stones . Several reports showed that FURS is a suitable alternative to shockwave lithotripsy (SWL) and percutaneous nephrolithotripsy (PCNL) for the treatment of renal stones, with potentially higher stone-free rates than SWL and lower morbidity than PCNL.

Safe and effective removal by FURS of multiple and large intrarenal stones, including lower pole calculi, has been documented suggesting that FURS is effective for complex intrarenal stone removal . With the multitude of available procedures, selection of the optimal one for management of renal stone is becoming more challenging.

Established models for predicting the outcomes of SWL and PCNL exist . However, a predictive model for predicting the outcome of URS is still in development , particularly for FURS treatment of renal stones. Four scores have been developed for FURS. Two of these have been compared and validated in different cohorts: the Resolu Unsal Stone Score (RUSS) and modified Seoul National University Renal Stone Complexity (S-ReSC) score , the other two scores, the S.T.O.N.E score described by Molina et al. and Ito's nomogram.

Many studies have demonstrated that stone volume is the most significant factor predictive of stone-free status (SF) after FURS. The investigators speculate that stone volume combined with other variables might improve prediction of SF after FURS. The aim of the present study is to evaluate various preoperative parameters as predictors of FURS outcome based on the Ito's nomogram

Study Type

Observational

Enrollment (Anticipated)

72

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

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with renal stones that are < 2 cm in maximal diameter will be recruited to the study. Patients will be counseled for flexible ureteroscopy, and the procedure will be explained to them with discussion about its pros and cons. Patients agreeable to enrollment will sign an informed written consent after fulfillment of ethical approval forms.Stone free rate will be assessed at one week, one month, and three months post-operatively using Plain X-ray for radio-opaque stones and NCCT for radiolucent stones.

Stone free rate will be determined by no stone fragment > 4mm. Number of ancillary procedures required to reach SF will be reported

Description

Inclusion Criteria:

  1. Renal stones (≤ 2 cm)
  2. Radiolucent stone resistant to SWL and oral chemical dissolution treatment (≤2cm)

Exclusion Criteria:

  1. Large stones (> 2 cm).
  2. Staghorn stone (stone involving the renal pelvis and more than two calyces).
  3. Patient preference of other treatment modality

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stone free rate after flexible ureteroscopy
Time Frame: baseline
the investigators predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free rate postoperatively.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Investigators

  • Principal Investigator: Mohamed Abdelgaber Selim, ASS-PROF, menofia universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FURS outcome prediciton

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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