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Clinical Trials in China / NCT06438497
Recruiting Not applicable

The Effect of Different Body Positions and Channel Sheaths on RIRS

NCT06438497 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Phase
Not applicable
Started
2024-05-23
Last updated
2024-09-24

Condition(s) studied

Urolithiasis

Investigational drug(s) / intervention(s)

RIRS with f-UAS, lateral positionRIRS with f-UAS, lithotomy positionRIRS with traditional UAS, lateral positionRIRS with traditional UAS, lithotomy position

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).

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).

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting

More The First Affiliated Hospital of Guangzhou Medical University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06438497 on ClinicalTrials.gov ↗ ← All trials in China