The Effect of Different Body Positions and Channel Sheaths on RIRS

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2024-11-30

Brief Summary

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Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm. Lower pole renal stones(LPS) are a difficult problem for urologists. The flexible negative pressure suction ureteral sheath(f-UAS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation.Standard lithotomy position is the most commonly used position for RIRS. Besides, T-tilt position is also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available in cases of LPS.In long-term practice, investigators have found that the change of position and the use of f-UAS can improve stone-free rate(SFR). Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.

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Detailed Description

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Urolithiasis was one of the most frequently noted diseases in urology clinic, with an incidence ranged from 5 to 15% around the world. Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm in size. Lower pole renal stones(LPS) are a difficult problem for urologists. The inborn sharp infundibular-pelvic angle (IPA) designated an inferior stone-free rate(SFR) of 65-82.5% in LPS when compared to middle and/or upper pole stone. The flexible negative pressure suction ureteral sheath(f-URS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation. Therefore, in cases of LPS, f-URS combined with RIRS may show advantages. However, there is currently a lack of relevant prospective randomized controlled studies. Standard lithotomy position is the most commonly used position for RIRS. Besides the standard lithotomy position, other positions, such as the T-tilt position, are also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available for RIRS in cases of LPS.Theoretically, in standard lithotomy position, the renal pelvis and renal calyces were mostly distributed in a '-\<' shaped structure on the horizontal plane. However, the renal pelvis and renal calyxes would be stood up in a 'Y'-shaped structure when patients laid in lateral position. And gravity will make the calyceal stones at the dome fall into the renal pelvis naturally during the lithotripsy. In long-term clinical practice, researchers have found that the change of position and the use of f-UAS can improve SFR. The investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RIRS with f-UAS, lateral position

In group 1, patients were placed on operating table in lateral position. A flexible negative-pressure suction ureteric access sheath (f-UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.

Group Type EXPERIMENTAL

RIRS with f-UAS, lateral position

Intervention Type PROCEDURE

In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).

RIRS with f-UAS, lithotomy position

In group 2, patients were placed on operating table in lithotomy position. A flexible negative-pressure suction ureteral access sheath (f-UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.

Group Type EXPERIMENTAL

RIRS with f-UAS, lithotomy position

Intervention Type PROCEDURE

In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).

RIRS with traditional UAS, lateral position

In group 3, patients were placed on operating table in lateral position. A traditional ureteric access sheath (UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.

Group Type EXPERIMENTAL

RIRS with traditional UAS, lateral position

Intervention Type PROCEDURE

In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.

RIRS with traditional UAS, lithotomy position

In group 4, patients were placed on operating table in lithotomy position. A traditional ureteral access sheath (UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.

Group Type ACTIVE_COMPARATOR

RIRS with traditional UAS, lithotomy position

Intervention Type PROCEDURE

In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.

Interventions

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RIRS with f-UAS, lateral position

In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).

Intervention Type PROCEDURE

RIRS with f-UAS, lithotomy position

In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A f-UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS. The tip of the UAS has good flexibility and deformability. It can passively bend with the bending of the flexible ureteroscope (f-URS).

Intervention Type PROCEDURE

RIRS with traditional UAS, lateral position

In this intervention, patients were placed on operating table in lateral position. The coronal plane of the patient body was perpendicular to the operating table. The upper limbs were extended and fxed with brackets. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.

Intervention Type PROCEDURE

RIRS with traditional UAS, lithotomy position

In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard. A traditional UAS is placed under the pelvi-ureteric junction (PUJ) in RIRS.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* LPS with a diameter of 10-20 mm
* American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ
* Adult patients

Exclusion Criteria

* Ureteric stricture
* Urethral deformity
* Renal malformation, including horseshoe kidney, ectopic kidney and transplanted kidney
* Pregnancy
* Multiple stones in diferent calyces, including upper pole and middle pole

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No