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Trial History Detail on 2009-11-20

CUHK_CCT00166

2008-07-15

Prospective

Nil

Research Grants Council General Research Fund

Division of Urology, Department of Surgery, the Chinese University of Hong Kong

NA

Ng Chi Fai

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

Phone: 26322625/ 26323953, Fax: 26377974,

e-mail: ngcf@surgery.cuhk.edu.hk

Associate Professor, Department of Surgery

Ng Chi Fai

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

Phone: 26322625/ 26323953, Fax: 26377974,

e-mail: ngcf@surgery.cuhk.edu.hk

Professor, Department of Surgery

A Prospective Study to Investigate the Effects of Different Shockwave Delivery Rates in Extracorporeal Shockwave Lithotripsy in Patients Suffer form Renal Calculi

A Prospective Study to Investigate the Effects of Different Shockwave Delivery Rates in Extracorporeal Shockwave Lithotripsy in Patients Suffer form Renal Calculi

Nil

Hong Kong

Yes

2008-03-13

Renal calculi

Procedure

Extracorporeal Shockwave Lithotripsy (ESWL)

1 day

All patients will be treated with ESWL but at a different shockwave delivery rate among groups

Inclusion criteria are: •Adult patient (aged ≥ 18 years old). •Solitary radio-opaque renal stones of size 5-20mm in maximal diameter as measured from plain radiography •Clinically decided for primary ESWL

Exclusion criteria are: •Stones associated with any renal or ureteric anatomical abnormality, such as caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction etc •Patients with ureteric stent or nephrostomy tube inserted •Patients with known history of cystine stone. •Patients with multiple stones in the same calix •Patient with history of allergy or any abnormal reaction alfentanil

>=18

nil

Both Male and Female

Interventional

Randomized

Dose comparison

Single-blind

Parallel

2008-08-01

220

Recruiting

Primary outcomes: Successful treatment •Defined as either stone free or presence of clinically insignificant residual fragments (less than 4mm) at 12 weeks after one session of lithotripsy. •This will be assessed by plain radiography and non-contrast computerized tomogram.

Secondary outcomes: •Degree of renal injury o The changes in the urine level (compared to pre-SWL level) of NAG, HA, NGAL and IL-18 of the two groups (different shockwave delivery rates) will be assessed. •Response of patients to the treatment o The following factors will be assessed and then compared between the two groups Maximal Pain score - Pain intensity verbal rating scale tool [8] will be used to assess the severity of pain at every 1000 shocks and at the end of treatment Analgesics consumption - the amount of additional usage of analgesics delivered by PCA will be recorded at the end of treatment.

No

2012-04-03


Yes

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