Urinary Infection and Colonization in Bone Procedures
Conditions: Urinary Tract Infection, Complications, Urinary Tract Infection (Diagnosis), Frailty
Sponsor: Tomas Bata Hospital, Czech Republic

STUDY PROTOCOL 
 
Urinary Infection and Colonization in Bone Procedures 
 
Version March 2025 
 
 
POPULATION:  
 
For seniors aged 65 and over undergoing surgery (bone procedures, traumatology, 
orthopedics) in acute or elective mode, the relationship between preoperative urinary 
tract infection/colonization (within 30 days before the procedure) and the occurrence 
of predefined postoperative complications will be monitored (during the 
hospitalization period of patients). Among the monitored signs before surgery will be 
urine collection (chemical + sediment - a common part of pre-anesthetic 
examination), in case of findings, collection for bacteriological examination will be 
indicated. Furthermore, subjective complaints (present, absent), presence of fever, 
whether the infection/findings in the urine were treated or not, performance of control 
urine examination (performed, not performed).  
The Clinical Frailty Scale  and any administered antibiotic treatment will 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, delirium 
development, infection occurrence, sepsis development, and death will be monitored. 
The patient's trajectory during hospitalization (which departments they will be treated 
in, including the length of hospitalization) will be recorded. 
The primary objective 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. 
The secondary objectives will be to determine the most common postoperative 
complication in patients with preoperative urinary colonization and in patients with 
proven urinary infection. Additionally, the relationship between the preoperative 
Clinical Frailty Scale score in the defined patient population and the occurrence of 
predefined postoperative complications will be assessed. The final secondary 
objective will be to determine preoperative antibiotic therapy in the preoperative 
period. 
The cohort of trauma patients undergoing surgery was chosen to ensure the 
homogeneity of the studied population (seniors aged 65 and over undergoing bone 
surgery). 
 
 
TYPE OF STUDY:  
- 
monocentric, prospective, comparative, observational 
 
CHARACTERISTICS OF THE EVALUATION SUBJECT GROUP (AGE 
STRUCTURE, GENDER, METHOD OF RECRUITMENT, REWARD FOR 
PARTICIPATIONS, etc):  
- 
Elective trauma procedures for seniors aged 65 and over, including acute 
trauma procedures for seniors aged 65 and over. 
- 
Women and men.  

- 
Recruitment at the time of indication for the procedure or setting the date of 
surgery, as part of the pre-anesthetic examination. 
- 
No reward for participation 
- 
 
PRIMARY OBJECTIVE: 
- 
The primary objective 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 complication 
 
SECONDARY OBJECTIVE:  
 
- 
To determine the most common postoperative complication in patients with 
preoperative urinary colonization. 
- 
To determine the most common postoperative complication in patients with 
proven urinary infection. 
- 
To determine the relationship between the preoperative Clinical Frailty Scale 
score in the defined patient population and the occurrence of predefined 
postoperative complications. 
- 
To determine preoperative antibiotic therapy in the preoperative period. 
 
ENTRY 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 (common part of pre-anesthetic 
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 urine findings: chemical + sediment examination 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 
 
 
MONITORED SIGNS BEFORE SURGERY 
- 
be urine collection (chemical + sediment - a common part of pre-anesthetic 
examination) 

- 
 in case of positive findings (bacteriura, pyuria, leukocytouria), collection for 
bacteriological examination will be indicated. 
- 
subjective complaints (present, absent) presence of fever,  
- 
whether the infection/findings in the urine were treated or not 
- 
performance of control urine examination (performed, not performed) 
- 
antibiotic therapy (yes, no, what kind of antibiotic treatment)  
- 
 
MONITORED SIGNS AFTER SURGERY 
- 
Temperature, fever  
- 
Circulatory instability ( 
- 
Infection development, origin  
- 
Sepsis development, origin  
- 
Delirium development (standard procedure), scale (CAM-ICU) 
- 
Patient trajectory during hospitalization 
- 
Administered antibiotic treatment and its duration  
- 
Respondent morbidity 
- 
Respondent mortalit 
 
STATISTICAL ANALYSIS PLAN  
- 
Data will be evaluated in collaboration with a statistician 
 
All patient data will be pseudo-anonymized, and patients will be assigned a 
numbeThis project does not differ from the standard procedure in practice in Tomas 
Bata Hospital Zlín, Czech Republic.