Effect of Preop Stent Duration on SFR and Secondary Intervention in RIRS

NCT07052188 | Completed

• 1 other identifier: HRÜ/24.21.46
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate how placing a stent before surgery (preoperative stenting or passive dilation) affects the success rate of retrograde intrarenal surgery (RIRS), which is performed for kidney stones. Specifically, we will examine whether stenting improves the chance of becoming stone-free after surgery and reduces the need for a second surgical procedure.

Conditions

Stone, Urinary; Stone, Kidney

Keywords

Ureteral stent; retrograde intrarenal surgery; prestenting; preoperative ureteral stenting

Outcome Measures

Primary Outcomes (2)

• Number of Participants with stone-free

  in the first month after surgery

• Number of Participants with additional surgery was needed

  in the first month after surgery

Secondary Outcomes (1)

• Number of Participants with postoperative complications

  within 1 month after surgery

Study Arms (3)

Patients will have RIRS without any preoperative double J (DJ) stenting

EXPERIMENTAL

Procedure: without any preoperative stenting

Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks.

EXPERIMENTAL

Procedure: (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks

Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.

EXPERIMENTAL

Procedure: Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.

Interventions

without any preoperative stenting PROCEDURE

Patients will have RIRS without any preoperative stenting.

Patients will have RIRS without any preoperative double J (DJ) stenting

(DJ) stent placed with sedation and undergo RIRS within 2-4 weeks PROCEDURE

Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks.

Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks.

Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. PROCEDURE

Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks

Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with an indication for RIRS (Retrograde Intrarenal Surgery)

You may not qualify if:

• Patients under 18 or over 65 years of age
• Patients who cannot be followed up in the postoperative period

Sponsors & Collaborators

• Bedreddin Kalyenci: lead

Study Sites (1)

Adıyaman University

Adıyaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Calculi; Kidney Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: June 26, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 28, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year after the completion of the study

Locations

TU (1)