Protocol No. 2016 - Calculosis- Endourology;

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

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.

Study Overview

• Status: Recruiting
• Conditions: Calculosis
• Intervention / Treatment: Other: Observation of patients suffering from kidney stones who undergo endoscopic surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Andrea Salonia, MD; Phone Number: 02 2643 5661; Email: salonia.andrea@hsr.it
• Study Contact Backup: Name: Alessia d'Arma, MSc; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Irccs Ospedale San Raffaele
      • Contact: Alessia d'Arma, MSc; Phone Number: 02 2643 5506; Email: darma.alessia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suffering from kidney stones who undergo endoscopic surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Calculosis patients; Patients suffering from kidney stones	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical data	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	Baseline and after 6 months
Eating habits	Eating habits through an ad-hoc eating habits questionnaire	Baseline and after 6 months
Prostatic Function	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.	Baseline and after 6 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Andrea Salonia, MD, Irccs Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2016
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2066

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: calculi; calculosis; endourologia
• Additional Relevant MeSH Terms: Pathologic Processes; Lithiasis
• Other Study ID Numbers: 2016 - Calcolosi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No