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NCT05340088 Clinical Trial

Optimal Passive Dilation Time in Retrograde Intrarenal Surgery

Urolithiasis Clinical Trial

Official title:
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05340088
Other study ID # DJRIRS2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date February 1, 2022

Study information
Verified date April 2022
Source Ankara Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with a DJ stent for passive dilatation and subsequent RIRC Exclusion Criteria: - Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Retrograde intrarenal surgery after DJ stent placement
Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation

Locations
Country Name City State
Turkey Ankara Training and Research Hospital Ankara Altindag

Sponsors (1)
Lead Sponsor Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bai PD, Wang T, Huang HC, Wu Z, Wang XG, Qin JX, Wang HQ, Chen B, Hu MB, Xing JC. Effect of Preoperative Double-J Ureteral Stenting before Flexible Ureterorenoscopy on Stone-free Rates and Complications. Curr Med Sci. 2021 Feb;41(1):140-144. doi: 10.1007/s11596-021-2328-z. Epub 2021 Feb 13. — View Citation

Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary BMI in kg/m^2 BMI in kg/m^2the kidney, operation time(minute) 3 Months
Primary serum creatinine mg/dl serum creatinine mg/dl 3 Months
Secondary mm size of the stone mm size of the stone 3 Months
Secondary localization of the stone in the kidney, localization of the stone in the kidney, 3 Months
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