Kidney CalculiNCT07655050
Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS
A study testing Standard Retrograde Intrarenal Surgery, Gentamicin Irrigation and Suction-Enabled Ureteral Access Sheath in people with Kidney Calculi and Urolithiasis, run by Hitit University at 2 sites in Turkey (Türkiye).
Trial summary
Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Urolithiasis, Urinary Tract Infections
- What is being tested?
- Standard Retrograde Intrarenal Surgery, Gentamicin Irrigation and Suction-Enabled Ureteral Access Sheath
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 8 May 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones
- Male and female patients aged 18 years or older
- Patients who voluntarily sign the informed consent form
- Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile
Who cannot join
- Patients with active urinary tract infection before surgery
- Patients with chronic kidney disease
- Pregnant patients
- Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin
- Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, 19040
MUSA EKİCİ, +90364 222 11 02, tipfak@hitit.edu.tr
AHMET TAŞCI
- Recruiting
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, 19040
MUSA EKİCİ, +90 505 751 63 41, musaekici@hitit.edu.tr
MUSTAFA SERDAR ÇAĞLAYAN
About this study
Official title: The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.
Read the detailed description
Subject:
The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.
Objective:
The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.
A potential mechanism for infectious complications after RIRS is increased intrarenal pressure during endoscopic lithotripsy. Elevated intrarenal pressure may promote pyelovenous and pyelolymphatic backflow, allowing bacteria, endotoxins, and inflammatory mediators from the collecting system or stone surface to enter the systemic circulation. Therefore, strategies that reduce bacterial contamination within the renal collecting system and improve intrarenal drainage may help decrease postoperative infectious morbidity.
This study is designed to evaluate two intraoperative strategies intended to reduce infectious complications during RIRS. The first strategy is local antibiotic irrigation using gentamicin-containing saline solution. Gentamicin will be added to the irrigation fluid as a local intraoperative measure rather than as a systemic treatment. This approach is intended to reduce bacterial contamination within the collecting system during lithotripsy. All patients will also receive standard systemic antibiotic prophylaxis according to routine clinical practice.
The second strategy is the use of a suction-enabled ureteral access sheath. This device is intended to improve fluid evacuation, reduce intrarenal pressure, and facilitate the removal of stone dust, debris, and potentially contaminated fluid during the procedure. By improving drainage from the collecting system, suction-assisted RIRS may theoretically reduce pyelovenous backflow and the risk of postoperative systemic inflammatory or infectious events.
The study uses a 2×2 factorial design, which allows simultaneous evaluation of the independent effects of gentamicin irrigation and suction-enabled ureteral access sheath use, as well as their combined effect. This design is useful because both interventions target different mechanisms that may contribute to infectious complications: local bacterial contamination and elevated intrarenal pressure. The factorial structure will also allow assessment of whether the combination of these two approaches provides an additive or synergistic benefit compared with either intervention alone.
All procedures will be performed under general anesthesia in the lithotomy position using standard endourological techniques. Irrigation will be performed with normal saline under low-pressure conditions. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline. In the suction groups, a suction-enabled ureteral access sheath will be used during flexible ureteroscopy. Stone fragmentation will be performed with a holmium:YAG laser using a dusting technique, and a double-J ureteral stent will be placed at the end of the procedure according to the study protocol.
This trial may provide clinically relevant evidence regarding infection-prevention strategies in RIRS. If gentamicin irrigation, suction-assisted access sheath use, or their combination is shown to reduce postoperative infectious complications without compromising surgical success, these approaches may contribute to safer perioperative management in endourological stone surgery.
- Conditions
- Kidney Calculi, Urolithiasis, Urinary Tract Infections
- Being tested
- Standard Retrograde Intrarenal Surgery, Gentamicin Irrigation, Suction-Enabled Ureteral Access Sheath
- Keywords
- Retrograde intrarenal surgery, Kidney stone, Gentamicin, Irrigation fluid, Infectious complications, Urinary tract infection, SEPSİS
- Medical subject headings
- Kidney Calculi, Urolithiasis, Urinary Tract Infections, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Retrograde Intrarenal SurgeryProcedure or surgery
Also called Standard RIRS Flexible Ureteroscopy
Standard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure.
Gentamicin IrrigationDrug
Also called Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:
Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment.
Suction-Enabled Ureteral Access SheathDevice
Also called Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath
A suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Standard RIRS | Experimental | Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention. Receives: Procedure: Standard Retrograde Intrarenal Surgery |
| Standard RIRS With Gentamicin Irrigation | Experimental | Arm Description:
Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance. Receives: Procedure: Standard Retrograde Intrarenal Surgery; Drug: Gentamicin Irrigation |
| Suction RIRS | Experimental | Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin. Receives: Device: Suction-Enabled Ureteral Access Sheath |
| Suction RIRS With Gentamicin Irrigation | Experimental | Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Receives: Drug: Gentamicin Irrigation; Device: Suction-Enabled Ureteral Access Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Fever
Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
Measured: Within 48 hours after surgery
Systemic Inflammatory Response Syndrome
Systemic inflammatory response syndrome will be defined as the presence of at least two of the following criteria: body temperature greater than 38°C or less than 36°C, heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, or white blood cell count greater than 12,000/mm³ or less than 4,000/mm³.
Measured: Within 48 hours after surgery
Sepsis
Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
Measured: Within 48 hours after surgery
Secondary outcomes (5)
Stone-Free Rate
Stone-free status will be evaluated using non-contrast computed tomography. Residual fragments of 4 mm or less will be considered clinically insignificant.
Measured: 4 weeks after surgery
Change in White Blood Cell Count
White blood cell count will be assessed before and after surgery to evaluate postoperative inflammatory response.
Measured: Baseline and within 48 hours after surgery
Change in Serum Creatinine
Serum creatinine levels will be assessed before and after surgery to evaluate renal function changes.
Measured: Baseline and within 48 hours after surgery
Urine Culture Positivity
Postoperative urine culture results will be evaluated to identify urinary tract infection and causative microorganisms.
Measured: Within 48 hours after surgery
Blood Culture Positivity
Postoperative blood culture results will be evaluated in patients with suspected systemic infection to identify bloodstream infection and causative microorganisms.
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Jun 2026
- Primary completion8 Feb 2027 (estimated)
- Study completion8 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies 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
- Factorial
- Model description
- Participants will be randomized into four parallel study arms using a 2×2 factorial design. The two factors evaluated in the study are gentamicin-containing irrigation and the use of a suction-enabled ureteral access sheath during retrograde intrarenal surgery. This design will allow assessment of the independent effects of each intervention as well as their combined effect on postoperative infectious complications.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Serdar CAGLAYAN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655050
- Sponsor's protocol ID
- ETIK-2026-22
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhong W, Leto G, Wang L, Zeng G. Systemic inflammatory response syndrome after flexible ureteroscopic lithotripsy: a study of risk factors. J Endourol. 2015 Jan;29(1):25-8. doi: 10.1089/end.2014.0409.
PubMed 24999535Rai A, Aro T, Lynch E, Tabib C, Mikhail D, Wang D, Abraham A, Hoenig D, Smith A, Okeke Z. Novel Irrigation Protocol for Renal Pelvis Sterilization During Percutaneous Nephrolithotomy: A Pilot Study. J Endourol. 2021 Sep;35(9):1320-1325. doi: 10.1089/end.2020.0695. Epub 2021 May 10.
PubMed 33752442Corrales M, Sierra A, Doizi S, Traxer O. Risk of Sepsis in Retrograde Intrarenal Surgery: A Systematic Review of the Literature. Eur Urol Open Sci. 2022 Aug 30;44:84-91. doi: 10.1016/j.euros.2022.08.008. eCollection 2022 Oct.
PubMed 36071820
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
- ClinicalTrials.gov ID
- NCT07655050
- Acronym / sponsor ID
- ETIK-2026-22
- Conditions
- Kidney Calculi, Urolithiasis, Urinary Tract Infections
- Keywords
- Retrograde intrarenal surgery, Kidney stone, Gentamicin, Irrigation fluid, Infectious complications, Urinary tract infection, SEPSİS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 8 Feb 2027 (estimated)
- Study completion
- 8 May 2027 (estimated)
- First posted
- 17 Jun 2026 (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.
Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.
Detailed description
Subject:
The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.
Objective:
The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.
A potential mechanism for infectious complications after RIRS is increased intrarenal pressure during endoscopic lithotripsy. Elevated intrarenal pressure may promote pyelovenous and pyelolymphatic backflow, allowing bacteria, endotoxins, and inflammatory mediators from the collecting system or stone surface to enter the systemic circulation. Therefore, strategies that reduce bacterial contamination within the renal collecting system and improve intrarenal drainage may help decrease postoperative infectious morbidity.
This study is designed to evaluate two intraoperative strategies intended to reduce infectious complications during RIRS. The first strategy is local antibiotic irrigation using gentamicin-containing saline solution. Gentamicin will be added to the irrigation fluid as a local intraoperative measure rather than as a systemic treatment. This approach is intended to reduce bacterial contamination within the collecting system during lithotripsy. All patients will also receive standard systemic antibiotic prophylaxis according to routine clinical practice.
The second strategy is the use of a suction-enabled ureteral access sheath. This device is intended to improve fluid evacuation, reduce intrarenal pressure, and facilitate the removal of stone dust, debris, and potentially contaminated fluid during the procedure. By improving drainage from the collecting system, suction-assisted RIRS may theoretically reduce pyelovenous backflow and the risk of postoperative systemic inflammatory or infectious events.
The study uses a 2×2 factorial design, which allows simultaneous evaluation of the independent effects of gentamicin irrigation and suction-enabled ureteral access sheath use, as well as their combined effect. This design is useful because both interventions target different mechanisms that may contribute to infectious complications: local bacterial contamination and elevated intrarenal pressure. The factorial structure will also allow assessment of whether the combination of these two approaches provides an additive or synergistic benefit compared with either intervention alone.
All procedures will be performed under general anesthesia in the lithotomy position using standard endourological techniques. Irrigation will be performed with normal saline under low-pressure conditions. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline. In the suction groups, a suction-enabled ureteral access sheath will be used during flexible ureteroscopy. Stone fragmentation will be performed with a holmium:YAG laser using a dusting technique, and a double-J ureteral stent will be placed at the end of the procedure according to the study protocol.
This trial may provide clinically relevant evidence regarding infection-prevention strategies in RIRS. If gentamicin irrigation, suction-assisted access sheath use, or their combination is shown to reduce postoperative infectious complications without compromising surgical success, these approaches may contribute to safer perioperative management in endourological stone surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized into four parallel study arms using a 2×2 factorial design. The two factors evaluated in the study are gentamicin-containing irrigation and the use of a suction-enabled ureteral access sheath during retrograde intrarenal surgery. This design will allow assessment of the independent effects of each intervention as well as their combined effect on postoperative infectious complications.
| Arm | Type | Receives |
|---|---|---|
| Standard RIRS | Experimental | Procedure: Standard Retrograde Intrarenal SurgeryParticipants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention. |
| Standard RIRS With Gentamicin Irrigation | Experimental | Procedure: Standard Retrograde Intrarenal Surgery, Drug: Gentamicin IrrigationArm Description: Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance. |
| Suction RIRS | Experimental | Device: Suction-Enabled Ureteral Access SheathParticipants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin. |
| Suction RIRS With Gentamicin Irrigation | Experimental | Drug: Gentamicin Irrigation, Device: Suction-Enabled Ureteral Access SheathParticipants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones
- Male and female patients aged 18 years or older
- Patients who voluntarily sign the informed consent form
- Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile
Key exclusion criteria (5 listed)
- Patients with active urinary tract infection before surgery
- Patients with chronic kidney disease
- Pregnant patients
- Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin
- Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation
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 |
|---|---|---|
| Standard Retrograde Intrarenal SurgeryAlso: Standard RIRS Flexible UreteroscopyStandard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure. | Procedure or surgery | Standard RIRS, Standard RIRS With Gentamicin Irrigation |
| Gentamicin IrrigationAlso: Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment. | Drug | Standard RIRS With Gentamicin Irrigation, Suction RIRS With Gentamicin Irrigation |
| Suction-Enabled Ureteral Access SheathAlso: Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access SheathA suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy. | Device | Suction RIRS, Suction RIRS With Gentamicin Irrigation |
Primary outcome
Postoperative Fever
Time frame: Within 48 hours after surgery
Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
Systemic Inflammatory Response Syndrome
Time frame: Within 48 hours after surgery
Systemic inflammatory response syndrome will be defined as the presence of at least two of the following criteria: body temperature greater than 38°C or less than 36°C, heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, or white blood cell count greater than 12,000/mm³ or less than 4,000/mm³.
Sepsis
Time frame: Within 48 hours after surgery
Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
5 secondary outcomes
Stone-Free Rate
Time frame: 4 weeks after surgery
Change in White Blood Cell Count
Time frame: Baseline and within 48 hours after surgery
Change in Serum Creatinine
Time frame: Baseline and within 48 hours after surgery
Urine Culture Positivity
Time frame: Within 48 hours after surgery
Blood Culture Positivity
Time frame: Within 48 hours after surgery
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 24 Jun 2026.
- Background: PubMed 24999535Zhong W, Leto G, Wang L, Zeng G. Systemic inflammatory response syndrome after flexible ureteroscopic lithotripsy: a study of risk factors. J Endourol. 2015 Jan;29(1):25-8. doi: 10.1089/end.2014.0409.
- Background: PubMed 33752442Rai A, Aro T, Lynch E, Tabib C, Mikhail D, Wang D, Abraham A, Hoenig D, Smith A, Okeke Z. Novel Irrigation Protocol for Renal Pelvis Sterilization During Percutaneous Nephrolithotomy: A Pilot Study. J Endourol. 2021 Sep;35(9):1320-1325. doi: 10.1089/end.2020.0695. Epub 2021 May 10.
- Background: PubMed 36071820Corrales M, Sierra A, Doizi S, Traxer O. Risk of Sepsis in Retrograde Intrarenal Surgery: A Systematic Review of the Literature. Eur Urol Open Sci. 2022 Aug 30;44:84-91. doi: 10.1016/j.euros.2022.08.008. eCollection 2022 Oct.
- Related InfoLink provided by the sponsor.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Retrograde Intrarenal Surgery, Gentamicin Irrigation and Suction-Enabled Ureteral Access Sheath in people with Kidney Calculi and Urolithiasis, run by Hitit University at 2 sites 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 4 inclusion and 5 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 MUSTAFA SERDAR ÇAĞLAYAN (+90 507 431 1951, serdar.09.09@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Fever (time frame: Within 48 hours after surgery). The study lists 3 primary outcomes in all. 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 NCT07655050, which also lists 3 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 24 Jun 2026.