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NCT Number: NCT06163313

Protocol No. 2016 - Calculosis- Endourology;

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.

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Key information

Conditions

Calculosis Calculi Lithiasis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Location contact

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation of patients suffering from kidney stones who undergo endoscopic surgery

Other

Clinical data will therefore be acquired through a collection of medical history, physical examination, blood chemistry and instrumental test reports;

Primary outcomes

  1. Clinical data

    Time frame: Baseline and after 6 months

    Medical history: patient's medical history, past surgical history, family medical history, social history, allergies, and medications; physical examination: vital signs, temperature examination, blood pressure, pulse, and respiratory rate blood chemistry and instrumental test reports: Serum PSA levels, conventional imaging

  2. Eating habits

    Time frame: Baseline and after 6 months

    Eating habits through an ad-hoc eating habits questionnaire

  3. Prostatic Function

    Time frame: Baseline and after 6 months

    Prostatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

Andrea Salonia, MD

CONTACT

[email protected]

02 2643 5661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2066
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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