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Recruiting NCT07247617

Flexible vs Semi-rigid URS

No phase Interventional Ureteric Stone Flexible Ureteroscopy Upper Urinary Tract Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flexible URS, Semi-Rigid URS.
Who it may be relevant to
Registry conditions: Ureteric Stone, Flexible Ureteroscopy, Upper Urinary Tract Stones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy in Upper Third Ureteric Stones Management: a Prospective Randomized Trial

Overview

To compare the efficacy, safety, success rate, operative time, and cost-effectiveness of flexible ureteroscopy versus semirigid ureteroscopy in the management of upper ureteric stones smaller than 2 cm. The investigators' main concern in this study is Upper third ureteric stones to determine which cases can be treated with Semi-Rigid Ureteroscopy, and which one needs flexible ureteroscopy. This depends on several factors: 1. Division of the upper third of the ureter 2. Stone size 3. Stone impaction 4. Surgeon experience 5. Anesthesia 6. Ureteric dilatation above the stone 7. Mini endoscopy

Detailed description

Ureteroscopy (URS) is a widely accepted minimally invasive approach for treating ureteric stones, particularly proximal (upper) ureteral stones. Options include rigid, semirigid (often grouped as one), and flexible ureteroscopes. Flexible ureteroscopy allows deflection and access to the proximal ureter and intrarenal collecting system, facilitating treatment of stones that are difficult to reach with rigid ureteroscopes due to anatomical constraints or stone migration. Semirigid ureteroscopy has shown good efficacy, particularly for stones amenable to direct access without complex deflection, offering shorter operative times and lower costs. Studies report stone-free rates of approximately 90-93% for flexible URS and 81-90% for semirigid URS, with flexible URS having somewhat higher success in accessing stones and managing fragment migration. However, flexible URS typically incurs higher costs and longer operative times. Semirigid ureteroscopy is often the initial approach for upper ureteric stones where anatomy, stone size (\<2 cm), and location allow straightforward access.

* Flexible ureteroscopy is preferred when stones are located higher in the ureter, difficult to reach by semirigid scopes, or if stone migration into the kidney occurs. It is also favored when more maneuverability is required to treat complex anatomy or large stones. * Both modalities use holmium laser lithotripsy for stone fragmentation. * Treatment choice also depends on surgeon preference, availability of equipment, and cost considerations.

Despite advances, there is ongoing debate about the optimal first-line ureteroscopic approach for upper ureteric stones, balancing efficacy, safety, cost, and procedure time. Comparing flexible and rigid/semirigid ureteroscopy outcomes informs treatment algorithms, improving patient care and resource utilization, especially in differing healthcare settings.

Interventions

  • Procedure Flexible URS
    Flexible URS
  • Procedure Semi-Rigid URS
    Semi-Rigid URS

Primary outcome measures

  • - Stone-free rate at 3 months duration [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Patients ≥18 years
  • upper ureteric stone
  • ≤20 mm

Exclusion criteria

  • Associated renal stones
  • Any contraindications to Anesthesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut Hospital — Asyut

Publications

  • Wright AE, Rukin NJ, Somani BK. Ureteroscopy and stones: Current status and future expectations. World J Nephrol. 2014 Nov 6;3(4):243-8. doi: 10.5527/wjn.v3.i4.243. PMID 25374818

Identifiers

NCT: NCT07247617 · Upper third ureteric stones

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗