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NCT Number: NCT05297331

Renal Stone Treatment Global Registry

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alice Ho Miu Ling Nethersole Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient at the age of 18 or above

Exclusion criteria

  • Patient is unable to give consent

Treatment and study plan

Primary outcomes

  1. Target Stone status

    Time frame: postoperative, at 1 and/or 3 months

    stone free rate

Secondary outcomes

  1. Intraoperative parameters

    Time frame: intraoperative

    Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics

  2. Treatment related complication

    Time frame: Thirty days after the operation

    The 30-day complications will be graded according to the Clavien-Dindo classification

  3. Recurrence of stone

    Time frame: At 12 months

    Stone recurrence rate

  4. QOL and pain scores

    Time frame: preoperative, postoperative on day 0 and at follow up

    Pain VAS scores and QOL assessment

Study contacts

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

Chi Fai NG, MD

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry

Important dates

Study start
2022
Primary completion
2032
Study completion
2033
First posted
Mar 28, 2022
Registry last updated
Apr 1, 2025

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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