NCT04894058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

May 16, 2021

Last Update Submit

May 21, 2021

Conditions

UreterolithiasisUreter StoneUreter Calculi

Keywords

Upper ureteral stoneUreteroscopic lithotripsyReverse Trendelenburg

Outcome Measures

Primary Outcomes (1)

  • Rate of stone migration

    Rate of patients who had a stone migration to renal pelvis or calyces during the operation

    One year

Study Arms (3)

10 ° reverse Trendelenburg

ACTIVE COMPARATOR

Patients who underwent ureteroscopic lithotripsy in the 10 ° reverse Trendelenburg position

Procedure: Ureteroscopic lithotripsy

20 ° reverse Trendelenburg

ACTIVE COMPARATOR

Patients who underwent ureteroscopic lithotripsy in the 20 ° reverse Trendelenburg position

Procedure: Ureteroscopic lithotripsy

Standard lithotomy

SHAM COMPARATOR

Patients who underwent ureteroscopic lithotripsy in standard lithotomy position

Procedure: Ureteroscopic lithotripsy

Interventions

Ureteroscopic lithotripsyPROCEDURE

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.

10 ° reverse Trendelenburg20 ° reverse TrendelenburgStandard lithotomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive upper ureteral stones

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 28271355BACKGROUND

  • 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.

    PMID: 28456350BACKGROUND

  • 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.

    PMID: 23165399BACKGROUND

  • 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.

    PMID: 22701479BACKGROUND

  • 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.

    PMID: 22264464BACKGROUND

  • 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.

    PMID: 23532427BACKGROUND

  • 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.

    PMID: 9334635BACKGROUND

  • 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.

    PMID: 23159589BACKGROUND

  • 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.

    PMID: 30098120BACKGROUND

  • Yildiz AK, Doluoglu OG, Kacan T, Keseroglu BB, Ozgur BC, Karakan T. A new position utilizing the effect of gravity in proximal ureteral stones, ureteroscopic lithotripsy in the reverse Trendelenburg position: a prospective, randomized, comparative study. World J Urol. 2023 Dec;41(12):3695-3703. doi: 10.1007/s00345-023-04654-y. Epub 2023 Oct 19.

    PMID: 37855898DERIVED

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Ali Kaan Yildiz

    Ankara Training and Resarch Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 20, 2021

Study Start

April 1, 2019

Primary Completion

December 1, 2020

Study Completion

April 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)