NCT06510790

Brief Summary

The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

July 12, 2024

Last Update Submit

July 18, 2024

Conditions

Bacterial Colonization in Double J Ureteral Stent

Keywords

ColonizationDouble J stentRisk factorsUrinary tract infection

Outcome Measures

Primary Outcomes (1)

  • Risk factors associated with bacterial colonization of DJS.

    Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.

    4 weeks

Secondary Outcomes (1)

  • The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.

    4 weeks

Study Arms (1)

Patients undergoing DJ stent

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures

Device: Double J stent

Interventions

Double J stentDEVICE

Double J ureteral catheter has been used to prevent upper urinary tract obstructions or strictures and to facilitate stone clearance after procedures such as percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and ureteroscopic lithotripsy (URSL).

Also known as: Ureteral stent
Patients undergoing DJ stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively.

You may qualify if:

  • \- Patients undergoing DJ stent placement

You may not qualify if:

  • Positive urine culture before stenting
  • Taking antibiotics during DJS removal
  • Presence of yeasts in urine culture
  • Declining informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medicine

Kathmandu, Bagmati, 44600, Nepal

Location

Biospecimen

Retention: SAMPLES WITH DNA

The retained biospecimens are the tips of both the renal and bladder ends of the double J ureteral stent. These tips are cut with a surgical blade and collected in a sterile plastic screw-capped container. They are then sent for bacterial culture and sensitivity testing to identify and evaluate the microorganisms present on the stent. The DNA of these microorganisms can be extracted and analyzed as part of the bacterial evaluation process.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 19, 2024

Study Start

March 1, 2022

Primary Completion

June 15, 2023

Study Completion

August 15, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

The Individual Participant Data (IPD) to be shared for registration on ClinicalTrials.gov will include demographic details (age, sex), preoperative characteristics (hemoglobin levels, albuminuria), procedural information (stent type, duration), microbiological findings (bacterial species, drug sensitivity), and clinical outcomes (complications, mortality). These data will facilitate analysis of risk factors for bacterial colonization in patients with double J ureteral stents and guide future research and clinical practice.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be made available after publication of manuscript in the journal.
Access Criteria
Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.

Locations

NE(1)