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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of urinary tract lithiasis (stones = 2cm) or urolithiasis with hydronephrosis Exclusion Criteria: - antimicrobial drugs been administered in the latest month - immunosuppressor been administered in the latest month - urinary tract infection or positive urine culture results - history of urinary calculi surgery - diabetes - chronic renal failure patients - neurogenic bladder dysfunction - abnormal anatomy of the kidney - neuromuscular dysfunction (spina bifida, paraplegia, green Barry syndrome, or quadriplegia) - more than 90 minutes operation time - more than 1000 ml blood loss |
Country | Name | City | State |
---|---|---|---|
China | Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665, | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Bag S, Kumar S, Taneja N, Sharma V, Mandal AK, Singh SK. One week of nitrofurantoin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. Urology. 2011 Jan;77(1):45-9. doi: 10.1016/j — View Citation
Sofikerim M, Gülmez I, Karacagil M. One week of ciprofloxacin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. BJU Int. 2007 Feb;99(2):466. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture. | Compared with control group, the positive rate of operative blood routine, CRP, urine routine, urine culture, procalcitonin , bacterial endotoxin test of experimental group are declining. | 3 or 7 days after operation | |
Secondary | Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs | Compared with control group, the positive rate of operative blood culture, procalcitonin are declining. | 3 or 7 days after operation |
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