Optimal Duration Between Drainage for Obstructing Renal or Ureteral Stones Associated With Infection and Ureteroscopic Lithotripsy: A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Percentage of postoperative infectious complications in treatment groups
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percentage of postoperative infectious complications in treatment groups
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed R EL-Nahas
Professor of Urology
Mansoura University