Duration Between Drainage and Ureteroscopic Lithotripsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ureter Stone Renal Stone Ureteric Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early

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

Group Type ACTIVE_COMPARATOR

Early ureteroscopy

Intervention Type PROCEDURE

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

Delayed

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

Group Type ACTIVE_COMPARATOR

Delayed Ureteroscopy

Intervention Type PROCEDURE

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

Interventions

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Early ureteroscopy

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

Intervention Type PROCEDURE

Delayed Ureteroscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No