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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06438497
Other study ID # MRER(84)2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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