Hydronephrosis Clinical Trials

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Long-Term Safety Outcomes of Ureteral Access Sheath-Assisted Versus Sheathless Retrograde Intrarenal Surgery for Renal Stones ≤20 mm in Non-Prestented Patients: A Retrospective Comparative Cohort Study With Active Follow-up

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

This retrospective comparative cohort study will include adult patients who underwent primary RIRS for renal stones ≤20 mm at Al-Azhar University Hospitals between January 2020 and December 2025. Patients will be classified by whether a ureteral access sheath (UAS) was used during the index RIRS, and all eligible patients will be invited for active long-term follow-up (minimum 12 months) to assess the composite outcome of delayed ipsilateral ureteral stricture or new/progressive ipsilateral hydronephrosis and other safety and efficacy outcomes. Propensity-score methods and adjusted regression analyses will be used to control confounding.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years at time of index RIRS.

• Primary RIRS performed at Al-Azhar University Hospitals between Jan 1, 2020 and Dec 31, 2025.

• Renal stone(s) with maximum diameter ≤20 mm on preoperative imaging.

• No ipsilateral ureteral stent or nephrostomy before index RIRS.

• Documented operative record specifying whether a UAS was used.

• At least 12 months elapsed since index RIRS.

• Available contact information allowing invitation for active follow-up.

Locations
Other Locations
Egypt
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
RECRUITING
Cairo
Contact Information
Primary
Abul-fotouh Ahmed
abulfotouhahmed@yahoo.com
+201001066756
Time Frame
Start Date: 2026-08-16
Estimated Completion Date: 2027-12-25
Participants
Target number of participants: 1200
Treatments
UAS-assisted RIRS cohort.
Adult patients with renal stones ≤20 mm who underwent primary retrograde intrarenal surgery using a ureteral access sheath and had no preoperative ipsilateral ureteral stent or nephrostomy.
Sheathless RIRS cohort.
Adult patients with renal stones ≤20 mm who underwent primary retrograde intrarenal surgery without a ureteral access sheath and had no preoperative ipsilateral ureteral stent or nephrostomy.
Related Therapeutic Areas
Sponsors
Leads: Al-Azhar University

This content was sourced from clinicaltrials.gov