Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong

Urolithiasis Clinical Trial

Official title:

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi in Hong Kong

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297331
• Other study ID #: CRE-2021.684
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 31, 2033

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Fai NG, MD
• Phone: 35052625
• Email: ngcf[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis in our hospital clusters.

Description:

Renal stone is a common condition in Hong Kong, 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.

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 internal audit, treatment comparison and also patient education.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2033
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at the age of 18 or above

Exclusion Criteria:

• Patient is unable to give consent

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urolithiasis

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin
Hong Kong	North District Hospital	Sheung Shui

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

Anagnostou T, Thompson T, Ng CF, Moussa S, Smith G, Tolley DA. Safety and outcome of percutaneous nephrolithotomy in the elderly: retrospective comparison to a younger patient group. J Endourol. 2008 Sep;22(9):2139-45. doi: 10.1089/end.2007.0432. — View Citation

Chan SW, Ng CF, Man CW, Chung R, Li SK. A report on a randomly sampled questionnaire survey about renal stone disease in Hong Kong. Hong Kong Med J. 2008 Dec;14(6):427-31. — View Citation

Li JK, Teoh JY, Ng CF. Updates in endourological management of urolithiasis. Int J Urol. 2019 Feb;26(2):172-183. doi: 10.1111/iju.13885. Epub 2018 Dec 21. — View Citation

Ng CF, Luke S, Chiu PK, Teoh JY, Wong KT, Hou SS. The effect of renal cortical thickness on the treatment outcomes of kidney stones treated with shockwave lithotripsy. Korean J Urol. 2015 May;56(5):379-85. doi: 10.4111/kju.2015.56.5.379. Epub 2015 Apr 28. — View Citation

Ng CF, Wong A, Tolley DA. A single-center experience of the usefulness of caliceal-pelvic height in three different lithotripters. J Endourol. 2008 Jul;22(7):1409-15. doi: 10.1089/end.2006.0448. — View Citation

Ng CF. The effect of age on outcomes in patients undergoing treatment for renal stones. Curr Opin Urol. 2009 Mar;19(2):211-4. doi: 10.1097/mou.0b013e32831e16b7. — View Citation

Taguchi K, Cho SY, Ng AC, Usawachintachit M, Tan YK, Deng YL, Shen CH, Gyawali P, Alenezi H, Basiri A, Bou S, Djojodemedjo T, Sarica K, Shi L, Singam P, Singh SK, Yasui T. The Urological Association of Asia clinical guideline for urinary stone disease. Int J Urol. 2019 Jul;26(7):688-709. doi: 10.1111/iju.13957. Epub 2019 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Stone status	The fragmentation rate of target stone	At 3 months
Primary	Recurrence of stone	Stone recurrent rate	At 12 months
Primary	Treatment related complication	The 30-day complications will be graded according to the Clavien-Dindo classification	Thirty days after the operation