The Effect of Different Body Positions and Channel Sheaths on RIRS
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2024
CompletedFirst Submitted
Initial submission to the registry
May 24, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 24, 2024
September 1, 2024
5 months
May 24, 2024
September 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (4)
Operative time
During surgery
Hemoglobin drop
1 day after surgery
Hospital stay
1 week
Complication rate
1 month after sugery
Study Arms (4)
RIRS with f-UAS, lateral position
EXPERIMENTALIn group 1, patients were placed on operating table in lateral position. A flexible negative-pressure suction ureteric access sheath (f-UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.
RIRS with f-UAS, lithotomy position
EXPERIMENTALIn group 2, patients were placed on operating table in lithotomy position. A flexible negative-pressure suction ureteral access sheath (f-UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.
RIRS with traditional UAS, lateral position
EXPERIMENTALIn group 3, patients were placed on operating table in lateral position. A traditional ureteric access sheath (UAS) is placed under the pelvi-ureteral junction (PUJ) in RIRS.
RIRS with traditional UAS, lithotomy position
ACTIVE COMPARATORIn group 4, patients were placed on operating table in lithotomy position. A traditional ureteral access sheath (UAS) is placed under the pelvi-ureteric junction (PUJ) in RIRS.
Interventions
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).
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).
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.
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.
Eligibility Criteria
You may qualify if:
- LPS with a diameter of 10-20 mm
- American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ
- Adult patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president
Study Record Dates
First Submitted
May 24, 2024
First Posted
June 3, 2024
Study Start
May 23, 2024
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
September 24, 2024
Record last verified: 2024-09