Duration Between Drainage and Ureteroscopic Lithotripsy

Renal Stone Clinical Trial

Official title:

Optimal Duration Between Drainage for Obstructing Renal or Ureteral Stones Associated With Infection and Ureteroscopic Lithotripsy: A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101563
• Other study ID #: 2371
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Ahmed R EL-Nahas, MD
• Phone: +201221136899
• Email: ar_el_nahas[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare early (one week) versus delayed (2-4 weeks) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.

Description:

All the study participants will be monitored during the early post-operative period for post-operative pain and complications. The rate and grade of reported complications will be determined according to modified Dindo-Clavian grading system. After ensuring safe status for discharge, all patients will be reassessed at the outpatient department after 4 weeks by NCCT to assess stone free status.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Obstructing ureteral or renal stone <20 mm.

2. Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).

Exclusion Criteria:

1. History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation.

2. Bilateral obstructed kidneys necessitating bilateral drainage.

3. Associated emphysematous pyelonephritis or perinephric abscess.

Related Conditions & MeSH terms

• Calculi
• Renal Stone
• Ureter Stone
• Ureteral Obstruction
• Ureteric Obstruction

Intervention

Procedure:
• Early ureteroscopy
Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices.
• Delayed Ureteroscopy
Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ureteroscopy Urosepsis.	infectious complication in presence of urinary tract infection with = two of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure < 90 mmHg & mean arterial pressure < 70 mmHg or systolic blood pressure decrease < 40 mmHg. - WBC >12,000 or <4,000.	2 days