Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
46 participants
INTERVENTIONAL
2016-02-29
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones according to European Association of Urology (EAU) guidelines on Urolithiasis will be included in the study after having signed an informed consent form. The pre- and post-operative evaluation and management will be performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative Doppler US will be performed in the first 24 hours following surgery. The changes on blood flow in renal artery and arcuate artery will be recorded.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones
NCT04894058
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones
NCT05738304
Laser Lithotripsy for Ureteral Stones
NCT06465784
Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery
NCT06809582
Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial
NCT04643145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones according to EAU guidelines on Urolithiasis will be included in the study after having signed an informed consent form. The pre- and post-operative evaluation and management will be performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative Doppler US will be performed in the first 24 hours following surgery. The changes on blood flow in renal artery and arcuate artery will be recorded.
Flexible ureteroscopy has been a key component of kidney stone management in the last 20 years. Even for stones larger than 2 cm, flexible ureteroscopy can be performed with high success and low complication rates. Ureteral access sheaths are key contributors to flexible ureteroscopy as they provide easy and repeated access to upper urinary tract and decreased intrarenal pressures due to easy flow back of the irrigation solution.
The increased pressures during flexible ureteroscopy have been an important research area in the last years. Due to irrigation solution and irrigational pumping to provide a clearer vision during flexible ureteroscopy, intrarenal pressures rise and after a certain point pyelo-sinusoidal, pyelo-venous and pyelo-lymphatic backflow starts. It has been shown that this backflow starts when pressure rises above 40 cmH2O (centimeters-water / unit of pressure measurement). Schwalb et al. demonstrated in their study that in kidneys subject to high intrarenal pressure, denudation and flattening of the caliceal urothelium, submucosal edema and congestion are observed. Due to these deleterious effects on urothelium, renal extravasation and bacterial translocation can occur and complications may arise.
Renal Doppler US, due to its non-invasive nature, has been widely used to measure localized blood flow in the kidneys, to evaluate hemodynamic parameters in acute kidney injury. Intrarenal backflow and its consequences such as submucosal edema and congestion may decrease blood flow especially around the calyces subject to high pressures and this situation may result in acute kidney injury.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flexible ureteroscopy arm
the findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Doppler Ultrasound examination has been performed in the pre-operative and post-operative periods
flexible ureteroscopy
Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.
Doppler Ultrasound examination
peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy
The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
flexible ureteroscopy
Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.
Doppler Ultrasound examination
peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
laser lithotripsy
The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU Guidelines on Urolithiasis
Exclusion Criteria
* Patients with already-diagnosed urological malignancies
* Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Marmara University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tarik Emre Sener, Urologist
Role: PRINCIPAL_INVESTIGATOR
Marmara University, School of Medicine, Department of Urology
References
Explore related publications, articles, or registry entries linked to this study.
Schwalb DM, Eshghi M, Davidian M, Franco I. Morphological and physiological changes in the urinary tract associated with ureteral dilation and ureteropyeloscopy: an experimental study. J Urol. 1993 Jun;149(6):1576-85. doi: 10.1016/s0022-5347(17)36456-x.
de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
Sener TE, Cloutier J, Villa L, Marson F, Buttice S, Doizi S, Traxer O. Can We Provide Low Intrarenal Pressures with Good Irrigation Flow by Decreasing the Size of Ureteral Access Sheaths? J Endourol. 2016 Jan;30(1):49-55. doi: 10.1089/end.2015.0387. Epub 2015 Sep 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09.2016.181
Identifier Type: OTHER
Identifier Source: secondary_id
MAR.UAD.002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.