Protocol No. 2016 - Calculosis- Endourology;

Recruiting

• Conditions: Calculosis
• Interventions: Other: Observation of patients suffering from kidney stones who undergo endoscopic surgery

• Registration Number: NCT06163313
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2016-09-17
• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2026-09-30
• Study Completion: 2066-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calculosis patients	Observation of patients suffering from kidney stones who undergo endoscopic surgery	Patients suffering from kidney stones

Primary Outcome Measures

Name	Time	Method
Eating habits	Baseline and after 6 months	Eating habits through an ad-hoc eating habits questionnaire
Prostatic Function	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.
Clinical data	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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy