Duration Between Drainage and Ureteroscopic Lithotripsy

October 20, 2023 updated by: Mansoura University

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

This study will be conducted to compare early (one week) versus delayed (2-4 weeks) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mahmoud E Helal, MD
  • Phone Number: +201069452118

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Recruiting
        • Urology and nephrology center
        • Contact:
        • Contact:
          • Mahmoud W Helal, MD
          • Phone Number: +201069452118
        • Sub-Investigator:
          • Mahmoud N Laymon, MD, MRCS
        • Sub-Investigator:
          • Elsawy A Amr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early
Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices (clinical and laboratory).
Procedure: Early ureteroscopy
Patients will be managed by ureteroscopic lithotripsy 7 days after normalization of inflammatory indices.
Active Comparator: Delayed
Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices (clinical and laboratory).
Procedure: Delayed Ureteroscopy
Patients will be managed by ureteroscopic lithotripsy 2-4 weeks after normalization of inflammatory indices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ureteroscopy Urosepsis.
Time Frame: 2 days
infectious complication in presence of urinary tract infection with ≥ two 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.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Yaser Osman, MD, Professor
  • Study Chair: Mahmoud Laymon, MD,MRCS, lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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