Clinical trial NCT05297331: Renal Stone Treatment Global Registry
Official title: A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urolithiasis
Keywords: Urolithiasis
ESWL
RIRS
flexible ureteroscopy
PCNL
FANS
flexible and navigable suction ureteral access sheath
intrarenal pressure
IRP
intrarenal temperature
IRT
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with urinary stones and planned for surgery (including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy (PCNL), laparoscopic ureterolithiasis, open stone procedures etc) in the hospitals will be identified and then enrolled to the study.

Brief summary: This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

Detailed description: Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.

New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.

Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.

Eligibility criteria: Inclusion Criteria:

* Patient at the age of 18 or above

Exclusion Criteria:

* Patient is unable to give consent

Primary outcomes:
measure: Target Stone status
timeFrame: postoperative, at 1 and/or 3 months
Secondary outcomes:
measure: Intraoperative parameters
timeFrame: intraoperative
measure: Treatment related complication
timeFrame: Thirty days after the operation
measure: Recurrence of stone
timeFrame: At 12 months
measure: QOL and pain scores
timeFrame: preoperative, postoperative on day 0 and at follow up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Sheung Shui
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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