NCT06101563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

October 20, 2023

Last Update Submit

November 6, 2024

Conditions

Ureter StoneRenal StoneUreteric Obstruction

Keywords

UreteroscopySepsisinfectious complicationsureteric calculiRenal calculi

Outcome Measures

Primary Outcomes (1)

  • Percentage of postoperative infectious complications in treatment groups

    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.

    30 days

Study Arms (2)

Early

ACTIVE COMPARATOR

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

Procedure: Early ureteroscopy

Delayed

ACTIVE COMPARATOR

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

Procedure: Delayed Ureteroscopy

Interventions

Early ureteroscopyPROCEDURE

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

Early
Delayed UreteroscopyPROCEDURE

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

Delayed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructing ureteral or renal stone \<20 mm.
  • Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

UreterolithiasisNephrolithiasisUreteral ObstructionSepsisKidney Calculi

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesKidney DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsUrinary CalculiCalculiPathological Conditions, Anatomical

Study Officials

  • Yaser Osman, MD

    Professor

    STUDY CHAIR

  • Mahmoud Laymon, MD,MRCS

    Lecturer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

May 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)