Duration Between Drainage and Ureteroscopic Lithotripsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ureter Stone, Renal Stone, Ureteric Obstruction

Intervention / Treatment
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* Procedure: Early ureteroscopy
* Procedure: Delayed Ureteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstructing ureteral or renal stone <20 mm. Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS). Exclusion Criteria: History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation. Bilateral obstructed kidneys necessitating bilateral drainage. Associated emphysematous pyelonephritis or perinephric abscess.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early<br>Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices (clinical and laboratory). | Procedure: Early ureteroscopy<br>* Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices.<br>|
| Active Comparator: Delayed<br>Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices (clinical and laboratory). | Procedure: Delayed Ureteroscopy<br>* Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteroscopy, Sepsis, infectious complications, ureteric calculi, Renal calculi