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Protocol No. 2016 - Calculosis- Endourology;

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06163313
Enrollment
15000
Registered
2023-12-08
Start date
2016-09-17
Completion date
2066-09-30
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculosis

Keywords

calculosis, calculi, endourologia

Brief summary

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

OTHERObservation 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;

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical dataBaseline and after 6 monthsMedical 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
Eating habitsBaseline and after 6 monthsEating habits through an ad-hoc eating habits questionnaire
Prostatic FunctionBaseline and after 6 monthsProstatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.

Countries

Italy

Contacts

Primary ContactAndrea Salonia, MD
salonia.andrea@hsr.it02 2643 5661
Backup ContactAlessia d'Arma, MSc
darma.alessia@hsr.it02 2643 5506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026