Skip to main content
OpenTrials
Completed

NCT Number: NCT06101563

Duration Between Drainage and Ureteroscopic Lithotripsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ureter Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Stone Sepsis Systemic Inflammatory Response Syndrome Ureteral Diseases Ureteral Obstruction Ureteric Obstruction Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early ureteroscopy

Procedure

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

Delayed Ureteroscopy

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.