Urinary InfectionsNCT06723327
The Effect of Preoperative Culture Timing on Postoperative Outcomes of Retrograde Intrarenal Surgery
An observational study of Urinary Infections and Urolithiasis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The rate of complications (unexpected situations) after retrograde intrarenal surgery is reported to be 9-25%, and the majority of these are postoperative infections. Surgery must be performed under sterile (microbial-free) urine culture to prevent these complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Infections, Urolithiasis
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of 950 patients with two negative preoperative urine cultures and patients with 50 positive urine cultures on the operation morning.
Who may be able to join
- Patients over 18 years of age
- Patients who had a urine culture taken 2 weeks before the operation and reported as sterile
Who cannot join
- Patients under 18 years of age
- Patients without sufficient data
- Patients with a urine culture more than 2 weeks before retrograde intrarenal -surgery
- Patients with a positive urine culture before retrograde intrarenal surgery
- Patients with renal anatomic anomalies
- Patients with a solitary (single) kidney
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tekirdag Namık Kemal University
Tekirdağ, 59020
Mehmet Fatih Şahin, 05555511871, mfatihsahin@gmail.com
About this study
The rate of complications (unexpected situations) after retrograde intrarenal surgery is reported to be 9-25%, and the majority of these are postoperative infections. Surgery must be performed under sterile (microbial-free) urine culture to prevent these complications. There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. The possibility of the patient becoming infectious again during the period leading up to surgery is a condition that needs to be determined. Therefore, the culture taken before surgery should be compared with the urine culture result taken at the latest possible time before the operation.
Read the detailed description
Retrograde Intrarenal Surgery (RIRC) (a surgery to fragment stones inside the kidney by entering from the distal end of the urinary tract with a camera system and light optical imaging device) is increasingly used today thanks to the developments in laser and scope (imaging device) technology. The risk of complications (unexpected situations) after this surgery is reported as 9-25%, most of which are infections. These infections can be severe conditions that can lead to septic shock (system failure due to severe infection) and death, as well as fever requiring only antipyretics (fever reducers).
Preventing infectious complications is as important as ensuring stone-free status for this surgery. For this purpose, surgery must be performed under sterile (microbe-free) urine culture. Patients with positive urine cultures should be taken to surgery due to increased pressure on the kidney, which can cause reflux (backflow of the kidney into the bloodstream) and infectious urine entering the circulation, leading to septicemia (microbes mixing into the bloodstream).
There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. In the American Urology guidelines, a sterile urine culture within 1 month is sufficient to be taken to surgery, but no period is specified in the European Urology guidelines. The possibility of the patient becoming infected again during the period leading up to surgery is a condition that needs to be determined. Therefore, the culture taken before surgery should be compared with the urine culture result taken at the latest possible period before the operation. This study aims to evaluate the preoperative and morning urine culture results and compare the postoperative results of patients with this difference.
- Conditions
- Urinary Infections, Urolithiasis
- Keywords
- urine culture, urolithiasis, kidney stone, retrograde intrarenal surgery
- Medical subject headings
- Urolithiasis, Kidney Calculi
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 |
|---|---|---|
| Patients with 2 sterile urine cultures | Before retrograde intrarenal surgery, patients with sterile urine culture 2 weeks before the surgery and morning urine culture | |
| Patients with only one sterile urine culture | Before retrograde intrarenal surgery, patients having sterile urine culture 2 weeks before the surgery and positive morning urine culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infection rates
Is there a difference in postoperative infectious complications between patients with two sterile preoperative urine cultures and patients with sterile cultures 2 weeks before the operation but positive urine cultures taken on the morning of the operation?
Measured: within 2 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 Urinary InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Fatih Şahin, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723327
- Sponsor's protocol ID
- 2024.304.11.11
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mekayten M, Heifetz EM, Sompolinsky Y, Lorber A, Duvdevani M, Strahilevitz J. Timing of midstream urine culture before endourological procedure-can we do better?-A comparative study. Urolithiasis. 2023 Aug 27;51(1):110. doi: 10.1007/s00240-023-01483-x.
PubMed 37634153Akkas F, Cinislioglu N, Haciislamoglu A, Atar FA, Guner E, Karadag S. Does time elapsed between urine culture and retrograde intrarenal surgery affect the rate of systemic inflammatory response syndrome? Actas Urol Esp (Engl Ed). 2022 May;46(4):223-229. doi: 10.1016/j.acuroe.2022.02.003. Epub 2022 Feb 21. English, Spanish.
PubMed 35210199
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Culture Timing on Postoperative Outcomes of Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT06723327
- Acronym / sponsor ID
- 2024.304.11.11
- Conditions
- Urinary Infections, Urolithiasis
- Keywords
- urine culture, urolithiasis, kidney stone, retrograde intrarenal surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- 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 rate of complications (unexpected situations) after retrograde intrarenal surgery is reported to be 9-25%, and the majority of these are postoperative infections. Surgery must be performed under sterile (microbial-free) urine culture to prevent these complications. There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. The possibility of the patient becoming infectious again during the period leading up to surgery is a condition that needs to be determined. Therefore, the culture taken before surgery should be compared with the urine culture result taken at the latest possible time before the operation.
Detailed description
Retrograde Intrarenal Surgery (RIRC) (a surgery to fragment stones inside the kidney by entering from the distal end of the urinary tract with a camera system and light optical imaging device) is increasingly used today thanks to the developments in laser and scope (imaging device) technology. The risk of complications (unexpected situations) after this surgery is reported as 9-25%, most of which are infections. These infections can be severe conditions that can lead to septic shock (system failure due to severe infection) and death, as well as fever requiring only antipyretics (fever reducers).
Preventing infectious complications is as important as ensuring stone-free status for this surgery. For this purpose, surgery must be performed under sterile (microbe-free) urine culture. Patients with positive urine cultures should be taken to surgery due to increased pressure on the kidney, which can cause reflux (backflow of the kidney into the bloodstream) and infectious urine entering the circulation, leading to septicemia (microbes mixing into the bloodstream).
There are guideline recommendations regarding sterile urine culture reporting, but it is not clear how long in advance it should be taken. In the American Urology guidelines, a sterile urine culture within 1 month is sufficient to be taken to surgery, but no period is specified in the European Urology guidelines. The possibility of the patient becoming infected again during the period leading up to surgery is a condition that needs to be determined. Therefore, the culture taken before surgery should be compared with the urine culture result taken at the latest possible period before the operation. This study aims to evaluate the preoperative and morning urine culture results and compare the postoperative results of patients with this difference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with 2 sterile urine cultures | – | –Before retrograde intrarenal surgery, patients with sterile urine culture 2 weeks before the surgery and morning urine culture |
| Patients with only one sterile urine culture | – | –Before retrograde intrarenal surgery, patients having sterile urine culture 2 weeks before the surgery and positive morning urine culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 950 patients with two negative preoperative urine cultures and patients with 50 positive urine cultures on the operation morning.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patients who had a urine culture taken 2 weeks before the operation and reported as sterile
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Patients without sufficient data
- Patients with a urine culture more than 2 weeks before retrograde intrarenal -surgery
- Patients with a positive urine culture before retrograde intrarenal surgery
- Patients with renal anatomic anomalies
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
Postoperative infection rates
Time frame: within 2 weeks after the surgery
Is there a difference in postoperative infectious complications between patients with two sterile preoperative urine cultures and patients with sterile cultures 2 weeks before the operation but positive urine cultures taken on the morning of the operation?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 37634153Mekayten M, Heifetz EM, Sompolinsky Y, Lorber A, Duvdevani M, Strahilevitz J. Timing of midstream urine culture before endourological procedure-can we do better?-A comparative study. Urolithiasis. 2023 Aug 27;51(1):110. doi: 10.1007/s00240-023-01483-x.
- Background: PubMed 35210199Akkas F, Cinislioglu N, Haciislamoglu A, Atar FA, Guner E, Karadag S. Does time elapsed between urine culture and retrograde intrarenal surgery affect the rate of systemic inflammatory response syndrome? Actas Urol Esp (Engl Ed). 2022 May;46(4):223-229. doi: 10.1016/j.acuroe.2022.02.003. Epub 2022 Feb 21. English, Spanish.
- Individual participant dataSharing planned: No
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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.
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 Urinary Infections and Urolithiasis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet F. Şahin, Assistant Professor (05555511871, mfatihsahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative infection rates (time frame: within 2 weeks after the surgery). 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 NCT06723327, 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 12 Dec 2024.