Duration Between Drainage and Ureteroscopic Lithotripsy

Not Applicable

Completed

• Conditions: Renal Stone; Ureter Stone; Ureteric Obstruction
• Interventions: Procedure: Early ureteroscopy; Procedure: Delayed Ureteroscopy

• Registration Number: NCT06101563
• Lead Sponsor: Mansoura University

Brief Summary

This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.

Detailed 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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-26
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early	Early ureteroscopy	Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices (clinical and laboratory).
Delayed	Delayed Ureteroscopy	Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices (clinical and laboratory).

Primary Outcome Measures

Name	Time	Method
Percentage of postoperative infectious complications in treatment groups	30 days	Difference in post-URS infectious complications between the study groups. infectious complications are defined as presence of urinary tract infection with one 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.

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt