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Recruiting NCT06163313

Protocol No. 2016 - Calculosis- Endourology;

Observational Calculosis

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: Observation of patients suffering from kidney stones who undergo endoscopic surgery.
Who it may be relevant to
Registry conditions: Calculosis. 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
Italy
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

Retrospective and Prospective Study of Patients Suffering From Nephrolithiasis Undergoing Surgery Using a Minimally Invasive Endoscopic Approach.

Overview

Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.

Detailed description

Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.

These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.

Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.

All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.

Interventions

  • Other Observation of patients suffering from kidney stones who undergo endoscopic surgery
    Clinical data will therefore be acquired through a collection of medical history, physical examination, blood chemistry and instrumental test reports;

Primary outcome measures

  • Clinical data [Time frame: Baseline and after 6 months]
  • Eating habits [Time frame: Baseline and after 6 months]
  • Prostatic Function [Time frame: Baseline and after 6 months]

Eligibility criteria

Inclusion criteria

  • subjects suffering from kidney stones or tumors of the upper excretory tract >= 18 years
  • signature of informed consent

Exclusion criteria

  • subjects < 18 years
  • presence of mental or physical disability that may prevent the patient from answering the questionnaires.

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT06163313 · 2016 - Calcolosi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗