RecruitingNot ApplicableNCT06438497

The Effect of Different Body Positions and Channel Sheaths on RIRS

The Effect of Different Body Positions and Channel Sheaths on Retrograde Intrarenal Stone Surgery(RIRS) Treatment of Lower Pole Renal Stones: a Randomized Controlled Trial


Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

120 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria5

  • 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

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Interventions

PROCEDURERIRS 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).

PROCEDURERIRS 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).

PROCEDURERIRS 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.

PROCEDURERIRS 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.


Locations(1)

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

Guangzhou, Guangdong, China

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NCT06438497


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