Duration Between Drainage and Ureteroscopic Lithotripsy

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06101563

Collaborator

(none)

100

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ureter Stone Renal Stone Ureteric Obstruction	Procedure: Early ureteroscopy Procedure: Delayed Ureteroscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Early

Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices (clinical and laboratory).

Procedure: Early ureteroscopy

Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices.

Active Comparator: Delayed

Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices (clinical and laboratory).

Procedure: Delayed Ureteroscopy

Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices.

Outcome Measures

Primary Outcome Measures

Post-ureteroscopy Urosepsis. [2 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.