Ureteral StonesNCT02635490
Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?
An observational study of Ureteral Stones, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureteral Stones
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Mar 2015
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort study
Who may be able to join
- 100 otherwise healthy adult patients.
- Aged from 20 to 65 years.
- Undergoing ureteroscopic procedures for ureteral stones.
Who cannot join
- Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
- Pregnant or the women been breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.
- Conditions
- Ureteral Stones
- Keywords
- prophylactic antibiotics, urinary tract infection.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| prophylactic antibiotics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.
Measured: within the first 10 days (plus or minus 5 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StonesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635490
- Sponsor's protocol ID
- 01-X20-068
- Status last verified
- Dec 2015
- First submitted
- 6 Aug 2014
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?
- ClinicalTrials.gov ID
- NCT02635490
- Acronym / sponsor ID
- 01-X20-068
- Conditions
- Ureteral Stones
- Keywords
- prophylactic antibiotics, urinary tract infection.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Dec 2015 (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.
The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prophylactic antibiotics | – | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort study
Key inclusion criteria (3 listed)
- 100 otherwise healthy adult patients.
- Aged from 20 to 65 years.
- Undergoing ureteroscopic procedures for ureteral stones.
Key exclusion criteria (2 listed)
- Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
- Pregnant or the women been breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.
Time frame: within the first 10 days (plus or minus 5 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Stones, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 2015. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture. (time frame: within the first 10 days (plus or minus 5 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2015.