NCT05340088

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 30, 2022

Last Update Submit

April 20, 2022

Conditions

Stone, KidneyUrolithiasis

Outcome Measures

Primary Outcomes (2)

  • BMI in kg/m^2

    BMI in kg/m\^2the kidney, operation time(minute)

    3 Months

  • serum creatinine mg/dl

    serum creatinine mg/dl

    3 Months

Secondary Outcomes (2)

  • mm size of the stone

    3 Months

  • localization of the stone in the kidney,

    3 Months

Study Arms (2)

Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation

Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation

Procedure: Retrograde intrarenal surgery after DJ stent placement

Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation

Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation

Procedure: Retrograde intrarenal surgery after DJ stent placement

Interventions

Retrograde intrarenal surgery after DJ stent placementPROCEDURE

Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation

Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatationPatients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a DJ stent for passive dilatation and subsequent RIRC

You may qualify if:

  • Patients with a DJ stent for passive dilatation and subsequent RIRC

You may not qualify if:

  • Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related 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.

    PMID: 33582918BACKGROUND

  • 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.

    PMID: 32928162BACKGROUND

MeSH Terms

Conditions

Kidney CalculiUrolithiasis

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 21, 2022

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

TU(1)