Complication of Surgical ProcedureEarly Phase 1NCT02789579
The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy
A Early Phase 1 study testing levofloxacin, Nitrofurantoin and cefuroxime in people with Complication of Surgical Procedure, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- levofloxacin, Nitrofurantoin and cefuroxime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pharmacy, Xinhua Hospital, Shanghai Jiaotong University School of Medicine.Kongjiang Road 1665,
Shanghai, Shanghai Municipality, 200092
Li lixia, Master, llxlyy88@sina.com
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Complication of Surgical Procedure
- Being tested
- levofloxacin, Nitrofurantoin, cefuroxime
- Keywords
- prophylactic, Urinary Tract Infections, Minimally invasive upper tract lithotomy
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
Also called Cravit
There are 50 patients in the group,each patient receives levofloxacin 0.5g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
NitrofurantoinDrug
Also called Furadantin
There are 50 patients in the group,each patient receives nitrofurantoin 0.1g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
cefuroximeDrug
Also called zinacef
There are 150 patients in the group, 30 minutes before surgery, each patient is given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| levofloxacin 3 days group | Experimental | There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 3 days before Minimally invasive upper tract lithotomy. Receives: Drug: levofloxacin; Drug: cefuroxime |
| nitrofurantoin 3 days group | Experimental | There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 3 days before Minimally invasive upper tract lithotomy. Receives: Drug: Nitrofurantoin; Drug: cefuroxime |
| cefuroxime group | Experimental | There are 150 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and does not receive oral antibiotics 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. Receives: Drug: cefuroxime |
| levofloxacin 7 days group | Experimental | There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 7 days before Minimally invasive upper tract lithotomy. Receives: Drug: levofloxacin; Drug: cefuroxime |
| nitrofurantoin 7 days group | Experimental | There are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 7 days before Minimally invasive upper tract lithotomy. Receives: Drug: Nitrofurantoin; Drug: cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 or 7 days after operation
Secondary outcomes (1)
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.
Measured: 3 or 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li lixia, Master, Principal investigator, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789579
- Sponsor's protocol ID
- XH-16-010
- Status last verified
- Sep 2019
- First submitted
- 15 Apr 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sofikerim M, Gulmez 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. doi: 10.1111/j.1464-410X.2007.06746_6.x. No abstract available.
PubMed 17313438Bag 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.urology.2010.03.025. Epub 2010 Jun 8.
PubMed 20570319
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Urinary Tract Infection Role of One Week Solutions of Antimicrobial Application Before Minimally Invasive Upper Tract Lithotomy
- ClinicalTrials.gov ID
- NCT02789579
- Acronym / sponsor ID
- XH-16-010
- Conditions
- Complication of Surgical Procedure
- Keywords
- prophylactic, Urinary Tract Infections, Minimally invasive upper tract lithotomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| levofloxacin 3 days group | Experimental | Drug: levofloxacin, Drug: cefuroximeThere are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 3 days before Minimally invasive upper tract lithotomy. |
| nitrofurantoin 3 days group | Experimental | Drug: Nitrofurantoin, Drug: cefuroximeThere are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 3 days before Minimally invasive upper tract lithotomy. |
| cefuroxime group | Experimental | Drug: cefuroximeThere are 150 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and does not receive oral antibiotics 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. |
| levofloxacin 7 days group | Experimental | Drug: levofloxacin, Drug: cefuroximeThere are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives levofloxacin 0.5g,qd,po 7 days before Minimally invasive upper tract lithotomy. |
| nitrofurantoin 7 days group | Experimental | Drug: Nitrofurantoin, Drug: cefuroximeThere are 30 patients in the group,each patient meets the eligibility criteria and does not meet the exclusion criteria,and receives nitrofurantoin 0.1g, tid, po 7 days before Minimally invasive upper tract lithotomy. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of urinary tract lithiasis (stones ≥ 2cm) or urolithiasis with hydronephrosis
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacinAlso: CravitThere are 50 patients in the group,each patient receives levofloxacin 0.5g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. | Drug | levofloxacin 3 days group, levofloxacin 7 days group |
| NitrofurantoinAlso: FuradantinThere are 50 patients in the group,each patient receives nitrofurantoin 0.1g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. | Drug | nitrofurantoin 3 days group, nitrofurantoin 7 days group |
| cefuroximeAlso: zinacefThere are 150 patients in the group, 30 minutes before surgery, each patient is given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours. | Drug | cefuroxime group, levofloxacin 3 days group, levofloxacin 7 days group, nitrofurantoin 3 days group, nitrofurantoin 7 days group |
Primary outcome
Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture.
Time frame: 3 or 7 days after operation
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.
1 secondary outcome
Evidence of clinically urosepsis confirmed by laboratory examination, urine bacterial culture, and vital signs
Time frame: 3 or 7 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Results publication: PubMed 17313438Sofikerim M, Gulmez 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. doi: 10.1111/j.1464-410X.2007.06746_6.x. No abstract available.
- Results publication: PubMed 20570319Bag 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.urology.2010.03.025. Epub 2010 Jun 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li lixia, Master principal investigator
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing levofloxacin, Nitrofurantoin and cefuroxime in people with Complication of Surgical Procedure, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li lixia, Master ((86)021-25078999, llxlyy88@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically urinary tract infection confirmed by laboratory examination or urine bacterial culture. (time frame: 3 or 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.