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

Sponsor
Menoufia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05857501
Collaborator
(none)
72
10.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: abdominopelvic computerized tomography (CT) without contrast

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 Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi
Anticipated Study Start Date :
May 10, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Outcome Measures

Primary Outcome Measures

  1. stone free rate after flexible ureteroscopy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Menoufia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
islam mohamed abou bakr mansour, Teaching Assistant, Menoufia University
ClinicalTrials.gov Identifier:
NCT05857501
Other Study ID Numbers:
  • FURS outcome prediciton
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2023