Urinary Infection and Colonization in Bone Procedures

NCT ID: NCT06896643

Last Updated: 2025-07-08

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

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-01

Brief Summary

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For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed

Detailed Description

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For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed Among the monitored parameters before the surgical procedure will be urine collection (chemical + sediment - a common part of the pre-anesthetic examination), and in case of findings, a sample for bacteriological examination will be indicated. Additionally, subjective symptoms (present, absent), presence of fever, whether the infection/finding in the urine was treated or not, and whether a control urine examination was performed (performed, not performed) will be recorded. The origin of the patient (home, social care facility) and the planned surgical procedure will be noted. The Clinical Frailty Scale, type of anesthesia (general, regional), and any administered antibiotic treatment will also be recorded.

After the surgical procedure, the occurrence of urinary infection (yes, no, sample not taken) will be assessed. Postoperative complications such as fever, circulatory instability, development of delirium, infection, septic state, and death will be monitored. The trajectory of the respondent during hospitalization (which departments they will be treated in, including the length of hospitalization) will be recorded. The primary goal will be to determine the relationship between the preoperative occurrence of urinary infection or colonization in patients within the last 30 days before the procedure and the occurrence of predefined postoperative complications. Secondary goals will include identifying the most common postoperative complications in patients with preoperative urinary colonization or proven urinary infection. Additionally, the relationship between the preoperative Clinical Frailty Scale in the defined patient population and the occurrence of predefined postoperative complications will be examined. The final secondary goal will be to determine preoperative antibiotic therapy in the preoperative period.

The cohort of traumatology patients undergoing surgical procedures was chosen to ensure the homogeneity of the studied population (seniors over 65 undergoing bone surgery).

Conditions

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Urinary Tract Infection Complications Urinary Tract Infection (Diagnosis) Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age over 65 years, including
* Elective or acute trauma/orthopedic bone surgery
* Urine examination as part of pre-anesthetic examination, urine + sediment, in case of suspicion - bacteriological examination
* Signed informed consent for research as part of pre-anesthetic examination (I or II), respecting informed consent as an expression of the patient's "free will"

Exclusion Criteria

* Negative finding in urine: chemical examination + sediment preoperatively
* Respondent under the influence of premedication, alcohol, or drugs
* Sensory impairment (blindness)
* Delirious preoperative state
* Severe mental disorder
* Sopor
* coma
* Septic state
* Acute respiratory failure
* Disagreement with participation in the study
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Klára Nekvindová

Deputy Chief for Science, Education, and Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tomas Bata Hospital

Zlín, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Klára Nekvindová, M.D., Ph.D.

Role: CONTACT

+420 577 551 111

Facility Contacts

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Klára Nekvindová, M.D., Ph.D.

Role: primary

+420 577 551 111

Tomáš Gabrhelík, doc., M.D., Ph.D.

Role: backup

+ 420 577 552 280

References

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Parvizi J, Koo KH. Should a Urinary Tract Infection Be Treated before a Total Joint Arthroplasty? Hip Pelvis. 2019 Mar;31(1):1-3. doi: 10.5371/hp.2019.31.1.1. Epub 2019 Mar 5.

Reference Type BACKGROUND
PMID: 30899708 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2024-32

Identifier Type: -

Identifier Source: org_study_id

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