Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones
Primary Purpose
Ureterolithiasis, Ureter Stone, Ureter Calculi
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ureteroscopic lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Ureterolithiasis focused on measuring Upper ureteral stone, Ureteroscopic lithotripsy, Reverse Trendelenburg
Eligibility Criteria
Inclusion Criteria:
- Obstructive upper ureteral stones
Exclusion Criteria:
- Presence of stent in the ureter at the beginning of the operation
- Serum creatinine value> 1.5 mg / dL
- Pathological ureteral strictures
- Previous open surgery history for the ureteral stone
- Previous pelvic radiotherapy history
- Pregnancy
- Solitary kidney
Sites / Locations
- Ankara Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
10 ° reverse Trendelenburg
20 ° reverse Trendelenburg
Standard lithotomy
Arm Description
Patients who underwent ureteroscopic lithotripsy in the 10 ° reverse Trendelenburg position
Patients who underwent ureteroscopic lithotripsy in the 20 ° reverse Trendelenburg position
Patients who underwent ureteroscopic lithotripsy in standard lithotomy position
Outcomes
Primary Outcome Measures
Rate of stone migration
Rate of patients who had a stone migration to renal pelvis or calyces during the operation
Secondary Outcome Measures
Full Information
NCT ID
NCT04894058
First Posted
May 16, 2021
Last Updated
May 21, 2021
Sponsor
Ankara Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04894058
Brief Title
Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones
Official Title
Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones: a Prospective, Randomized, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study investigated a previously unassessed operating position for ureteroscopic holmium laser lithotripsy in patients with upper ureteral stone. The reverse Trendelenburg position can reduce migration and improve the stone free rate (SFR). Moreover, less utilization of flexible ureteroscope and hospital stay in reverse Trendelenburg position can reduce the medical cost. Therefore, it can be safely used as an optional surgical method for the treatment of upper ureteral stones.
Detailed Description
With the rapid development of urological endoscopy technology, minimally invasive surgery has replaced open surgery in ureteral stones. The majority of upper ureteral stones are treated with endoscopic techniques. In the last 10 years, URSL (Ureteroscopic Lithotripsy) has surpassed SWL (Shock-wave lithotripsy) with its wide use [1]. While URSL was considered in the foreground according to SWL for proximal ureteral stones larger than 1 cm, today it is recommended with equal efficiency and safety with SWL for stones smaller than 1 cm [2]. However, migration of stones to renal calyces is a common problem during ureteroscopic treatment of upper ureteral stones. Migration can be caused by many factors such as the momentum of the laser pulse, stone manipulation of the laser fiber, fluid irrigation pressure and the increase of ureteral dilatation. The degree of migration varies according to the impaction level of the stone and the location in the ureter [3].
The migration of the stone to the renal pelvis and calyces increases the operation time and cost [4-6]. Recently published American Urological Association Guidelines reported that ureteroscopy of ureteral stones performed an average of 1.33 procedures per patient [7]. In order to prevent stone migration, tools have been developed that are used in the proximal of the stone or that interfere with the stone in the kidney after retreatment. Although these developed devices are effective, it has been determined that their additional use causes an additional cost of $ 278 per case as well as extending the operation time [8]. In addition, placing an anti-migration device in the ureter can restrict laser fiber manipulation. Ureterorenoscopes (Flexible URS) that can flex 270 degrees, which can be used to intervene in the stone after retraction into the kidney, have made a very serious improvement, but these devices are not yet available in all centers, especially in developing countries.
There is an in-vitro study using polymer tubes that predict that the proximal ureter should stay higher than the distal ureter in order to prevent retrograde in proximal ureteral stones [9].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiasis, Ureter Stone, Ureter Calculi
Keywords
Upper ureteral stone, Ureteroscopic lithotripsy, Reverse Trendelenburg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 ° reverse Trendelenburg
Arm Type
Active Comparator
Arm Description
Patients who underwent ureteroscopic lithotripsy in the 10 ° reverse Trendelenburg position
Arm Title
20 ° reverse Trendelenburg
Arm Type
Active Comparator
Arm Description
Patients who underwent ureteroscopic lithotripsy in the 20 ° reverse Trendelenburg position
Arm Title
Standard lithotomy
Arm Type
Sham Comparator
Arm Description
Patients who underwent ureteroscopic lithotripsy in standard lithotomy position
Intervention Type
Procedure
Intervention Name(s)
Ureteroscopic lithotripsy
Intervention Description
After combined spinal and epidural anesthesia, patients were subjected to low pressure perfusion; The semirigid ureteroscope was passed through the urethra to the bladder, after which both ureteral orifices were observed. A 0.035 "soft-tipped guidewire was sent through the ureter orifice and reached the renal pelvis. Subsequently, the patients were placed in the reverse trendelenburg position by leaning 10 ° or 20 ° with their head up and hips down or standard lithotomy position. The ureter stone was accessed with a semirigid ureteroscope. A 273 micron Holmium: yttrium-aluminum-garnet (Ho: YAG) laser was applied as an energy source set at 1.0 J and a speed of 8-10 Hz.
Primary Outcome Measure Information:
Title
Rate of stone migration
Description
Rate of patients who had a stone migration to renal pelvis or calyces during the operation
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obstructive upper ureteral stones
Exclusion Criteria:
Presence of stent in the ureter at the beginning of the operation
Serum creatinine value> 1.5 mg / dL
Pathological ureteral strictures
Previous open surgery history for the ureteral stone
Previous pelvic radiotherapy history
Pregnancy
Solitary kidney
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Organizational Affiliation
Ankara Training and Resarch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28271355
Citation
Santiago JE, Hollander AB, Soni SD, Link RE, Mayer WA. To Dust or Not To Dust: a Systematic Review of Ureteroscopic Laser Lithotripsy Techniques. Curr Urol Rep. 2017 Apr;18(4):32. doi: 10.1007/s11934-017-0677-8.
Results Reference
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PubMed Identifier
28456350
Citation
Drake T, Grivas N, Dabestani S, Knoll T, Lam T, Maclennan S, Petrik A, Skolarikos A, Straub M, Tuerk C, Yuan CY, Sarica K. What are the Benefits and Harms of Ureteroscopy Compared with Shock-wave Lithotripsy in the Treatment of Upper Ureteral Stones? A Systematic Review. Eur Urol. 2017 Nov;72(5):772-786. doi: 10.1016/j.eururo.2017.04.016. Epub 2017 Apr 26.
Results Reference
background
PubMed Identifier
23165399
Citation
Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
Results Reference
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PubMed Identifier
22701479
Citation
Cicerello E, Merlo F, Maccatrozzo L. Management of Clinically Insignificant Residual Fragments following Shock Wave Lithotripsy. Adv Urol. 2012;2012:320104. doi: 10.1155/2012/320104. Epub 2012 May 31.
Results Reference
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PubMed Identifier
22264464
Citation
Sea J, Jonat LM, Chew BH, Qiu J, Wang B, Hoopman J, Milner T, Teichman JM. Optimal power settings for Holmium:YAG lithotripsy. J Urol. 2012 Mar;187(3):914-9. doi: 10.1016/j.juro.2011.10.147. Epub 2012 Jan 20.
Results Reference
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PubMed Identifier
23532427
Citation
Pan J, Chen Q, Xue W, Chen Y, Xia L, Chen H, Huang Y. RIRS versus mPCNL for single renal stone of 2-3 cm: clinical outcome and cost-effective analysis in Chinese medical setting. Urolithiasis. 2013 Feb;41(1):73-8. doi: 10.1007/s00240-012-0533-8. Epub 2012 Dec 23.
Results Reference
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PubMed Identifier
9334635
Citation
Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.
Results Reference
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PubMed Identifier
23159589
Citation
Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
Results Reference
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PubMed Identifier
30098120
Citation
Patel RM, Walia AS, Grohs E, Okhunov Z, Landman J, Clayman RV. Effect of positioning on ureteric stone retropulsion: 'gravity works'. BJU Int. 2019 Jan;123(1):113-117. doi: 10.1111/bju.14510. Epub 2018 Sep 9.
Results Reference
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Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones
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