Ureteric Stent After Stone SurgeryNCT01768364
Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery
A study testing Trimetoprim-Sulfa (Bactrim) and No antibiotics in people with Ureteric Stent After Stone Surgery, run by Tor Erik Sand at 1 site in Norway.
Trial summary
Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureteric Stent After Stone Surgery
- What is being tested?
- Trimetoprim-Sulfa (Bactrim) and No antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Apr 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stone surgery patients with ureteric stent that should be removed after 14 days
Who cannot join
- ongoing antibiotic treatment, allergy to trimetoprim-sulfa
Trial locations and contacts
1 site in 1 country.
Tor Erik Sand, MD, PhD contact
Manuela Estop-Garanto, MD contact
Norway1 site
Akershus University Hospital
Lorenskog, Lorenskog, 1478
Manuela Estop-Garanto, MD, mnet@ahus.no
Tor Erik Sand, MD, PhD, tor.erik.sand@ahus.no
About this study
Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?
Read the detailed description
Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.
- Conditions
- Ureteric Stent After Stone Surgery
- Being tested
- Trimetoprim-Sulfa (Bactrim), No antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimetoprim-Sulfa (Bactrim)Drug
No antibioticsOther
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Active comparator | will receive antibiotics Receives: Drug: Trimetoprim-Sulfa (Bactrim) |
| No antibiotics | Active comparator | will not receive antibiotics Receives: Other: No antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
14 days infection rate w/wo antibiotics
Measured: 14 days
Secondary outcomes (1)
infection rate with ureter stent wo antibiotics
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric Stent After Stone SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Erik Sand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Erik Sand, Oslo and Akershus University College
- Investigators
- Tor Erik Sand, MD. PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768364
- Sponsor's protocol ID
- 2012/953
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery
- ClinicalTrials.gov ID
- NCT01768364
- Acronym / sponsor ID
- 2012/953
- Conditions
- Ureteric Stent After Stone Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Tor Erik SandUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 15 Jan 2013 (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.
Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?
Detailed description
Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Active comparator | Drug: Trimetoprim-Sulfa (Bactrim)will receive antibiotics |
| No antibiotics | Active comparator | Other: No antibioticswill not receive antibiotics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- stone surgery patients with ureteric stent that should be removed after 14 days
Key exclusion criteria (1 listed)
- ongoing antibiotic treatment, allergy to trimetoprim-sulfa
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 |
|---|---|---|
| Trimetoprim-Sulfa (Bactrim) | Drug | Antibiotics |
| No antibiotics | Other | No antibiotics |
Primary outcome
14 days infection rate w/wo antibiotics
Time frame: 14 days
1 secondary outcome
infection rate with ureter stent wo antibiotics
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
Related trials for Ureteric Stent After Stone Surgery
Recruiting
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones
Kidney Stone, Retrograde Intrarenal Surgery
Recruiting
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
Stone, Kidney, Stone Ureter
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.
Tor Erik Sand, MD, PhD contact
Manuela Estop-Garanto, MD contact
Tor Erik Sand, MD. PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimetoprim-Sulfa (Bactrim) and No antibiotics in people with Ureteric Stent After Stone Surgery, run by Tor Erik Sand at 1 site in Norway.
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 1 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 15 Jan 2013. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tor Erik Sand, MD, PhD (tor.erik.sand@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14 days infection rate w/wo antibiotics (time frame: 14 days). 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 15 Jan 2013.