Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Location status: Recruiting
NCT Number: NCT06438497
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510230, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 day
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.
Time frame: 1 month
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.
Time frame: During surgery
Surgery duration, minutes
Time frame: 1 day after surgery
Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L
Time frame: 1 week
Duration of hospital stay after surgery, days
Time frame: 1 month after sugery
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
Contact information is provided by the study sponsor or research team.
Guohua Zeng, Ph.D and M.D
CONTACT
Wen Zhong, Ph.D and M.D
CONTACT
The First Affiliated Hospital of Guangzhou Medical University
Other
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
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