Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438497
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
The Effect of Different Body Positions and Channel Sheaths on RIRS
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
The Effect of Different Body Positions and Channel Sheaths on Retrograde Intrarenal Stone SurgeryRIRS Treatment of Lower Pole Renal Stones a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrograde flexible ureteroscopy RIRS is currently the first-line treatment for renal stones 2cm Lower pole renal stonesLPS are a difficult problem for urologists The flexible negative pressure suction ureteral sheathf-UAS can facilitate RIRS to flush out the fragments and dust in time and provide a clear vision and reduce the renal pelvis pressureRPP during operationStandard 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 LPSIn long-term practice investigators have found that the change of position and the use of f-UAS can improve stone-free rateSFR Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths
Detailed 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 stonesLPS are a difficult problem for urologists The inborn sharp infundibular-pelvic angle IPA designated an inferior stone-free rateSFR of 65-825 in LPS when compared to middle andor upper pole stone The flexible negative pressure suction ureteral sheathf-URS can facilitate RIRS to flush out the fragments and dust in time and provide a clear vision and reduce the renal pelvis pressureRPP 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 LPSTheoretically 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None