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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early | Active Comparator | Patients will be managed by ureteroscopic lithotripsy 7 days after drainage. |
|
| Delayed | Active Comparator | Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early ureteroscopy | Procedure | Patients will be managed by ureteroscopic lithotripsy 7 days after drainage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of postoperative infectious complications in treatment groups | 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaser Osman, MD | Professor | Study Chair |
| Mahmoud Laymon, MD,MRCS | Lecturer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805964 | Derived | Helal ME, El-Nahas AR, Laymon M, Elsawy AA, Osman Y. Optimal duration between drainage for obstructing renal or ureteral stones associated with infection and ureteroscopic lithotripsy: a randomized controlled trial. World J Urol. 2026 Mar 10;44(1):227. doi: 10.1007/s00345-025-06124-z. |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D053040 | Nephrolithiasis |
| D014517 | Ureteral Obstruction |
| D018805 | Sepsis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Delayed Ureteroscopy | Procedure | Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage. |
|
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |