Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS
NCT ID: NCT02501525
Last Updated: 2019-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-08-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UAS (+)
RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
RIRS with ureteral access sheath
Ureteral access sheath will be used during RIRS.
UAS (-)
RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
RIRS without ureteral access sheath
Ureteral access sheath will not be used during RIRS.
Interventions
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RIRS with ureteral access sheath
Ureteral access sheath will be used during RIRS.
RIRS without ureteral access sheath
Ureteral access sheath will not be used during RIRS.
Eligibility Criteria
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Inclusion Criteria
* Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
Exclusion Criteria
* Patients with blood pressure \> 140/80 mmHg despite regular use of antihypertensive agent(s)
* Patients with chronic kidney failure who need dialysis
* Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
* Patients who have had pyelonephritis 3 months or much earlier
* Patients younger than 18 years or older than 70 years
* Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
* Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
* Patients using any kind of medication that can affect his/her perception of pain
18 Years
70 Years
ALL
No
Sponsors
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Selcuk University
OTHER
Responsible Party
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Ozcan Kilic
M.D., Assoc. Prof. Dr.
Principal Investigators
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Ozcan Kilic, M.D.
Role: PRINCIPAL_INVESTIGATOR
Selcuk University, School of Medicine, Department of Urology
Locations
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Selcuk University, School of Medicine, Department of Urology
Konya, , Turkey (Türkiye)
Countries
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References
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Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish.
Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631.
Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. doi: 10.1016/j.urology.2005.03.019.
Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. doi: 10.1089/end.2007.9997.
Lallas CD, Auge BK, Raj GV, Santa-Cruz R, Madden JF, Preminger GM. Laser Doppler flowmetric determination of ureteral blood flow after ureteral access sheath placement. J Endourol. 2002 Oct;16(8):583-90. doi: 10.1089/089277902320913288.
Torricelli FC, De S, Hinck B, Noble M, Monga M. Flexible ureteroscopy with a ureteral access sheath: when to stent? Urology. 2014 Feb;83(2):278-81. doi: 10.1016/j.urology.2013.10.002. Epub 2013 Nov 12.
Other Identifiers
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SU-RIRS-UAS-03
Identifier Type: -
Identifier Source: org_study_id
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