Complication of Surgical Procedure Clinical Trial
Official title:
The Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy
Minimally invasive upper tract lithotomy is currently a common operation method on treatment
of urinary tract stones, but the postoperative complication urinary tract infection or
urinary sepsis has turned into a serious threat to the patient's life, when severe, can
result in a higher death rate.Although more the more importance were attached to, an
effective prevention measures still have not been found.
Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of
postoperative urinary tract infection. The conventional postoperative prophylaxis medicine
was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that
continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence
of urinary sepsis. So the investigators assume that preoperative extended use time of
prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis.
This study uses a computerized random method. According to preoperative use of different
antimicrobial drug or treatment, all patients are randomly divided into five groups, namely
levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin
7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po,
the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better
antibiotics types, medication timing and duration of treatment to prevent postoperative
infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of
postoperative urinary tract infection or sepsis.
1. Sample Calculation: Based on the literature, the occurrence rate of fever after
Percutaneous Nephrolithotripsy (PCNL) was 21% -39.8%, urinary tract infection rate 38%,
SIRS rate 11.2%, the incidence rate of urinary sepsis 0.3% - 4.7%,and the mortality rate
with sepsis was 60% -80%. Expected incidence rate of urinary tract infection decreased
to 23%, and the difference is statistically significant. Provided that the case of the
two groups is equal, the expected strength of evidence is 0.9, α = 0.05, the lost up to
20%, the investigators calculated that the minimum sample size required is 150 cases.
Urology department has 70 ward beds with PCNL surgery or Flexible Ureteroscopy
Lithotripsy (FURL) about 400 cases per year, and the sample size can meet the study
requirements. All cases are from outpatient or emergency department.
2. Grouping and medication: This study uses a computerized random method. According to
preoperative use of different antimicrobial drug or treatment, all patients are randomly
divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group,
nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.and each
group of levofloxacin group or nitrofurantoin group has been given prophylactic for 3 or
7 days. The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin
group was given oral nitrofurantoin 100mg, tid, po. All patients in cefuroxime group, 30
minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and
continue using 1.5g q12h ivgtt until postoperative 48 hours.
3. Sterilization or bacterial culture: Surgical areas is disinfected with 10%
povidone-iodine, all surgical instruments are sterilized by high-temperature steam.
after renal pelvises are punctured, some urine is extracted for bacterial culture.
Stones removed by surgery are fragmented into small fragments, and stored at 36.5 ℃
tubes within a day in order to facilitate the proliferation of bacteria, then grown in
culture medium for bacterial culture.
4. Preoperative items observed: urinalysis, urine culture, renal function, blood, CRP,
procalcitonin, bacterial endotoxin test, kidney function, body temperature changes
prophylactic or preoperative. Imaging tests include urinary tract calculi line
pyelography and CT.
5. Postoperative follow-up: urine, urine culture, renal function, blood routine, CRP,
procalcitonin, bacterial endotoxin test, renal function and urinary tract stones line
urography and CT examination were made in all patients. Vital signs such as body
temperature, heart rate and blood pressure once every two hours were monitored in 48
hours, and were monitored every 4 hours after 48 hours. Blood routine was checked daily
until 3 days postoperative or 48 hours after abatement of fever. When white blood cell
count> 12 × 109 / L and / or body temperature> 38 ℃ °, it is considered to be systemic
inflammatory response (SIRS, modified Sepsis Diagnostic Criteria). Renal fistula was
retained for 48 hours Postoperative, and pleural effusion fistula was removed if there
was no fever after it was pinched 24 hours.
6. Statistical analysis: Statistical Product and Service Solutions (SPSS)19.0 statistical
software was used for analysis. Count data were analyzed by analysis of variance or t
Test. Measurement data were analyzed by Chi-square Test. The results were evaluated
within the safe range of 95%,when P <0.05,it was statistically significant.
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