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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04746378 -
PRedictive Accuracy of Initial Stone Burden Evaluation.
|
||
Recruiting |
NCT05100017 -
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
|
N/A | |
Recruiting |
NCT04021381 -
Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi
|
Phase 3 | |
Completed |
NCT02266381 -
A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
|
N/A | |
Completed |
NCT01451931 -
Study of Tomography of Nephrolithiasis Evaluation
|
Phase 4 | |
Terminated |
NCT01431378 -
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
|
N/A | |
Completed |
NCT02895711 -
Radiation Dose of Pediatric Patients During Ureteroscopy
|
||
Completed |
NCT01295879 -
Vitamin D Repletion in Stone Formers With Hypercalciuria
|
Phase 4 | |
Completed |
NCT05340075 -
Staged Bilateral Percutaneous Nephrolithotomy
|
||
Recruiting |
NCT03919227 -
Measurement of Resistance During UAS Insertion Procedure in RIRS
|
N/A | |
Recruiting |
NCT03717285 -
Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS
|
N/A | |
Completed |
NCT05340088 -
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
|
||
Completed |
NCT05032287 -
Medical Expulsive Therapy Post-SWL For Renal Stones
|
N/A | |
Recruiting |
NCT05701098 -
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
|
N/A | |
Not yet recruiting |
NCT04080973 -
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
|
N/A | |
Terminated |
NCT01736358 -
The Use of Intranasal Ketoralac for Pain Management (Sprix)
|
Phase 4 | |
Completed |
NCT01792765 -
Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach
|
N/A | |
Completed |
NCT06211842 -
Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
|
||
Not yet recruiting |
NCT02214836 -
Ultrasound Imaging of Kidney Stones and Lithotripsy
|
N/A | |
Not yet recruiting |
NCT04606758 -
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
|
N/A |