The Effect of Different Body Positions and Channel Sheaths on RIRS

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438497
• Other study ID #: MRER(84)2024
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, Ph.D and M.D
• Phone: +8613802916676
• Email: gzgyzgh[@]vip.tom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• LPS with a diameter of 10-20 mm

• American Society of Anesthesiologists(ASA) score ?,? and ?

• 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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Procedure:
• 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, lithotomy position
In this intervention, patients were placed on operating table in lithotomy position. This position is common and standard.

Locations

Country	Name	City	State
China	Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone-free rate	A low-dose and ultrathin 2-mm spiral CT was performed at 1 day postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.	1 day
Primary	Stone-free rate	A low-dose and ultrathin 2-mm spiral CT was performed at 1 month postoperatively for evaluation of fnal SFR. Stone-free status was defined as no fragments observed or clinically insignifcant residual fragments (CIRF)<2 mm.	1 month
Secondary	Operative time	Surgery duration, minutes	During surgery
Secondary	Hemoglobin drop	Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L	1 day after surgery
Secondary	Hospital stay	Duration of hospital stay after surgery, days	1 week
Secondary	Complication rate	Complication is defined as any adverse event occurred intraoperatively or =1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system	1 month after sugery