The impact of urinary infection on recovery after bone surgery
| ISRCTN | ISRCTN15440804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15440804 |
| ClinicalTrials.gov number | NCT06896643 |
| Secondary identifying numbers | 2024-32 |
- Submission date
- 10/07/2025
- Registration date
- 10/07/2025
- Last edited
- 10/07/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Older adults often experience urinary tract infections (UTIs) or bacterial colonization in their urinary system, even without symptoms. This study investigates whether such infections, occurring within 30 days before bone surgery, lead to complications during hospital recovery. The goal is to better understand this connection and help medical teams make more informed decisions when preparing patients for surgery. Improving preoperative screening and treatment could lead to safer outcomes for future patients.
Who can participate?
Patients aged 65 years or older and scheduled for bone surgery, either planned (elective) or emergency
What does the study involve?
Before surgery, participants will have their urine tested using routine chemical, microscopic, and bacteriological methods. If signs of infection or colonization are found, these results will be tracked during hospitalization. No additional treatments or procedures beyond standard hospital care will be introduced.
What are the possible benefits and risks of participating?
Participation carries minimal risk, as the urine tests are routine and non-invasive. Some patients might experience mild discomfort during urine sample collection, especially if a catheter is used. However, contributing to this research could help shape better care pathways for others in the future.
Where is the study run from?
Tomas Bata Hospital (Czech Republic)
When is the study starting and how long is it expected to run for?
December 2024 to July 2026
Who is funding the study?
Tomas Bata Hospital (Czech Republic)
Who is the main contact?
Dr Klára Nekvindová, klara.nekvindova@bnzlin.cz
Contact information
Public, Scientific, Principal Investigator
Návesní 9, Mladcová
Zlín
76001
Czech Republic
 ORCID ID |
0000-0003-4119-4916 |
|---|---|
| Phone | +420 (0)733325546 |
| klara.nekvindova@bnzlin.cz |
Study information
| Study design | Prospective longitudinal multicentre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention, Quality of life, Screening, Treatment, Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Incidence and impact of urinary tract colonization and infection on postoperative recovery in patients undergoing bone surgery: a prospective observational study |
| Study acronym | URIBONE |
| Study objectives | 1. To assess whether urinary tract infection (UTI) or colonization within 30 days prior to bone-related surgical procedures in patients aged 65 years and older is associated with an increased risk of postoperative complications during hospitalization. 2. To explore the impact of specific preoperative factors—such as untreated infection, absence of follow-up urine testing, and clinical signs (e.g. fever or subjective symptoms)—on the development and severity of postoperative complications. 3. To determine whether patient frailty, measured by the Clinical Frailty Scale, influences the likelihood of postoperative complications in patients with urinary tract infection or colonization. 4. To investigate whether patient origin (home vs social care facility) affects the incidence and severity of postoperative complications related to urinary tract status. |
| Ethics approval(s) |
Approved 10/12/2024, Tomas Bata Hospital Ethics Committee (Havlíčkovo nábřeží 600, 762 75, Zlín, 76275, Czech Republic; +420 (0)604994504; etickakomise@bnzlin.cz), ref: 2024-32 |
| Health condition(s) or problem(s) studied | Urinary infection and colonization before bone surgery |
| Intervention | Participants aged 65 years and older will be enrolled prior to bone-related surgical procedures and observed throughout their hospitalization. Before surgery, urine analysis (chemical and sediment) will be performed as part of the pre-anesthetic evaluation, with bacteriological sampling indicated in case of findings. Additional data will be recorded, including symptoms, fever, infection treatment status, follow-up testing, frailty score, planned surgery type, patient origin, anesthesia type, and antibiotic use. Following surgery, the occurrence of urinary infections and predefined postoperative complications (e.g. fever, delirium, septic state, death) will be monitored, along with the patient's hospital trajectory and length of stay. The total duration of observation and follow-up will correspond to the entire inpatient period from admission to discharge. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Urinary tract infection, assessed via clinical symptoms (dysuria, urgency, fever, nausea, etc) at 1 week before surgery |
| Secondary outcome measures | 1. Urinary tract infection measured using urine dipstick test for nitrate-reductase and leukocyte esterase at 1 week before surgery 2. Urinary tract infection measured using chemical examination of urine and sediment: pH ≥6 at 1 week before surgery 3. Urinary tract infection measured using urine dipstick test for proteinuria at 1 week before surgery 3. Urinary tract infection measured using urine dipstick test for leukocyturia (leukocyte esterase detection) at 1 week before surgery 4. Urinary tract infection measured using urine dipstick test for pyuria (leukocyte esterase or nitrites) and observation of urine discoloration, clouding or smell change at time 1 week before surgery 5. Urinary tract infection measured using urine dipstick test for bacteriuria (leukocyte esterase and nitrites) at 1 week before surgery 6. Urinary tract infection measured using flow cytometry for bacteriuria (40–1000 bacteria/μl) at 1 week before surgery 7. Urinary tract infection measured using urine culture for bacteriuria (≥100,000 CFU/ml) at 1 week before surgery 8. Urinary tract infection measured using sulfosalicylic acid laboratory test for proteinuria (semiquantitative scale from opalescence to flocculent precipitate) at 1 week before surgery 9. Urinary tract infection measured using [urine sediment microscopy for leukocyturia (>10 leukocytes per field of view)] at 1 week before surgery 10. Urinary tract infection measured using [urine sediment microscopy for pyuria (>10 leukocytes per field of view) and observation of urine discoloration, clouding or smell change at 1 week before surgery 11. Urinary tract colonization (women) measured using urine culture from two clean-catch specimens (≥100,000 CFU/ml of same species) at 1 week before surgery 12. Urinary tract colonization (men) measured using urine culture from one clean-catch specimen (≥100,000 CFU/ml) at 1 week before surgery 13. Urinary tract colonization (catheterized specimen) measured using urine culture from one specimen (≥100 CFU/ml) at 1 week before surgery 14. Antibiotic therapy measured using record of preoperative antibiotic use and type at 1 week before surgery 15. Postoperative fever measured using body temperature >38°C at 1 week after surgery 16. Postoperative circulatory instability measured using blood pressure: MAP <70 mmHg at 1 week after surgery 17. Postoperative infection measured using clinical presentation and laboratory findings at 1 week after surgery 18. Postoperative sepsis measured using clinical presentation and laboratory findings at 1 week after surgery 19. Postoperative delirium measured using CAM-ICU assessment at 1 week after surgery 20. Postoperative antibiotic therapy measured using record of administration and duration at 1 week after surgery |
| Overall study start date | 08/12/2024 |
| Completion date | 25/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Age over 65 years, including 2. Elective or acute trauma/orthopedic bone surgery 3. Urine examination as part of pre-anesthetic examination, urine + sediment, in case of suspicion - bacteriological examination 4. Signed informed consent for research as part of pre-anesthetic examination (I or II) |
| Key exclusion criteria | 1. Negative finding in urine: chemical examination + sediment preoperatively. 2. Respondent under the influence of premedication, alcohol, or drugs. 3. Sensory impairment (blindness) 4. Delirious preoperative state 5. Severe mental disorder 6. Sopor 7. Coma 8. Septic state 9. Acute respiratory failure 10. Disagreement with participation in the study |
| Date of first enrolment | 25/07/2025 |
| Date of final enrolment | 25/07/2026 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Zlín
76275
Czech Republic
Sponsor information
Hospital/treatment centre
Havlíčkovo nábřeží 600
Zlín
76275
Czech Republic
| Phone | +420 (0)577 551 111 |
|---|---|
| klara.nekvindova@bnzlin.cz | |
| Website | https://www.kntb.cz |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 25/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The dataset generated and/or analyzed during the current study will be published as a supplement to the results publication. |
Editorial Notes
10/07/2025: Study's existence confirmed by the Tomas Bata Hospital Ethics Committee.
