Duration Between Drainage and Ureteroscopic Lithotripsy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06101563

Enrollment

Registered

2023-10-26

Start date

2023-05-01

Completion date

2024-07-01

Last updated

2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone, Ureteric Obstruction, Ureter Stone

Keywords

Ureteroscopy, Sepsis, infectious complications, ureteric calculi, Renal calculi

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.

Interventions

PROCEDUREEarly ureteroscopy

Patients will be managed by ureteroscopic lithotripsy 7 days after drainage.

PROCEDUREDelayed Ureteroscopy

Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026