Urolithiasis Clinical Trial
Official title:
Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy Treatment of Moderate Sized Renal Pelvic Stones: A Randomized Prospective Study
Verified date | August 2018 |
Source | Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). However, the possible effect of pre-stenting on success as well as complication rates after SWL has not been evaluated in detail to date. Taking this fact into account, the effect of pre-stenting on the outcomes of SWL treatment in renal stones must be evaluated in the absence of possible effects induced by the patient and stone-related factors. Aim: To evaluate the effect of double J (JJ) stents on SWL treatment of moderate sized (15-25-mm) renal pelvic stones. Study design: Randomized prospective study Methods: Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; nonstented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
Status | Completed |
Enrollment | 92 |
Est. completion date | December 30, 2017 |
Est. primary completion date | December 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria:Between January 2016 and December 2017, a total of 152 adult (age > 18
years) patients who were planned to undergo ESWL for a single radiopaque renal pelvic stone
with a largest diameter of 15 to 25 mm were included in the study. Exclusion Criteria: - Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients, who have JJ stent or not, with successful SWL treatment. | Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session. | 15 weeks |
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