Duration Between Drainage and Ureteroscopic Lithotripsy

Mansoura University

Status: Completed

Conditions: Renal Stone; Ureteric Obstruction; Ureter Stone

Treatments: Procedure: Delayed Ureteroscopy; Procedure: Early ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06101563

2371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Early

Active Comparator group

Description:

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

Treatment:

Procedure: Early ureteroscopy

Delayed

Active Comparator group

Description:

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

Treatment:

Procedure: Delayed Ureteroscopy