Ureteroscopic Lithotripsy in the Reverse Trendelenburg Position for Upper Ureteral Stones

NCT ID: NCT04894058

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-04-01

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].

Conditions

Ureterolithiasis; Ureter Stone; Ureter Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

10 ° reverse Trendelenburg

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

Group Type: ACTIVE_COMPARATOR

Ureteroscopic lithotripsy

Intervention Type: PROCEDURE

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.

20 ° reverse Trendelenburg

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

Group Type: ACTIVE_COMPARATOR

Ureteroscopic lithotripsy

Intervention Type: PROCEDURE

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.

Standard lithotomy

Patients who underwent ureteroscopic lithotripsy in standard lithotomy position

Group Type: SHAM_COMPARATOR

Ureteroscopic lithotripsy

Intervention Type: PROCEDURE

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.

Interventions

Ureteroscopic lithotripsy

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Kaan Yildiz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Kaan Yildiz

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Resarch Hospital

Locations

Ankara Training and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

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Reference Type: BACKGROUND

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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.

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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.

Reference Type: DERIVED

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Other Identifiers

RT2021

Identifier Type: -

Identifier Source: org_study_id