PDF(Pubmed)
Abstract：
BACKGROUND: The aim was to ascertain the impact of irrigation technique on human intrarenal pressure during retrograde intrarenal surgery.
METHODS: A parallel randomized trial recruited patients across three hospital sites. Patients undergoing retrograde intrarenal surgery for renal stone treatment with an 11/13-Fr ureteral access sheath were allocated randomly to 100 mmHg pressurized-bag (PB) or manual hand-pump (HP) irrigation. The primary outcome was mean procedural intrarenal pressure. Secondary outcomes included maximum intrarenal pressure, variance, visualization, HP force of usage, procedure duration, stone clearance, and clinical outcomes. Live intrarenal pressure monitoring was performed using a COMETTMII pressure guidewire, deployed cystoscopically to the renal pelvis. The operating team was blinded to the intrarenal pressure.
RESULTS: Thirty-eight patients were randomized between July and November 2023 (trial closure). The final analysis included 34 patients (PB 16; HP 18). Compared with PB irrigation, HP irrigation resulted in significantly higher mean intrarenal pressure (mean(s.d.) 62.29(27.45) versus 38.16(16.84) mmHg; 95% c.i. for difference in means (MD) 7.97 to 40.29 mmHg; P = 0.005) and maximum intrarenal pressure (192.71(106.23) versus 68.04(24.16) mmHg; 95% c.i. for MD 70.76 to 178.59 mmHg; P < 0.001), along with greater variance in intrarenal pressure (log transformed) (6.23(1.59) versus 4.60(1.30); 95% c.i. for MD 0.62 to 2.66; P = 0.001). Surgeon satisfaction with procedural vision reported on a scale of 10 was higher with PB compared with HP irrigation (mean(s.d.) 8.75(0.58) versus 6.28(1.27); 95% c.i. for MD 1.79 to 3.16; P < 0.001). Subjective HP usage force did not correlate significantly with transmitted intrarenal pressure (Pearson R = -0.15, P = 0.57). One patient (HP arm) developed urosepsis.
CONCLUSIONS: Manual HP irrigation resulted in higher and more fluctuant intrarenal pressure trace (with inferior visual clarity) than 100-mmHg PB irrigation.
BACKGROUND: osf.io/jmg2h (https://osf.io/).
METHODS: A parallel randomized trial recruited patients across three hospital sites. Patients undergoing retrograde intrarenal surgery for renal stone treatment with an 11/13-Fr ureteral access sheath were allocated randomly to 100 mmHg pressurized-bag (PB) or manual hand-pump (HP) irrigation. The primary outcome was mean procedural intrarenal pressure. Secondary outcomes included maximum intrarenal pressure, variance, visualization, HP force of usage, procedure duration, stone clearance, and clinical outcomes. Live intrarenal pressure monitoring was performed using a COMETTMII pressure guidewire, deployed cystoscopically to the renal pelvis. The operating team was blinded to the intrarenal pressure.
RESULTS: Thirty-eight patients were randomized between July and November 2023 (trial closure). The final analysis included 34 patients (PB 16; HP 18). Compared with PB irrigation, HP irrigation resulted in significantly higher mean intrarenal pressure (mean(s.d.) 62.29(27.45) versus 38.16(16.84) mmHg; 95% c.i. for difference in means (MD) 7.97 to 40.29 mmHg; P = 0.005) and maximum intrarenal pressure (192.71(106.23) versus 68.04(24.16) mmHg; 95% c.i. for MD 70.76 to 178.59 mmHg; P < 0.001), along with greater variance in intrarenal pressure (log transformed) (6.23(1.59) versus 4.60(1.30); 95% c.i. for MD 0.62 to 2.66; P = 0.001). Surgeon satisfaction with procedural vision reported on a scale of 10 was higher with PB compared with HP irrigation (mean(s.d.) 8.75(0.58) versus 6.28(1.27); 95% c.i. for MD 1.79 to 3.16; P < 0.001). Subjective HP usage force did not correlate significantly with transmitted intrarenal pressure (Pearson R = -0.15, P = 0.57). One patient (HP arm) developed urosepsis.
CONCLUSIONS: Manual HP irrigation resulted in higher and more fluctuant intrarenal pressure trace (with inferior visual clarity) than 100-mmHg PB irrigation.
BACKGROUND: osf.io/jmg2h (https://osf.io/).
摘要：
背景：目的是确定逆行肾内手术期间冲洗技术对人体肾内压力的影响。
方法：一项平行随机试验招募了三家医院的患者。接受11/13-Fr输尿管入路鞘逆行肾内手术治疗肾结石的患者随机分配到100mmHg加压袋（PB）或手动泵（HP）冲洗。主要结果是平均程序肾内压力。次要结果包括最大肾内压力，方差，可视化,HP使用力,程序持续时间,石材间隙,和临床结果。使用COMETTMII压力导丝进行实时肾内压力监测，膀胱镜下部署到肾盂。操作团队对肾内压力视而不见。
结果：在2023年7月至11月之间随机分配了38例患者（试验结束）。最终分析包括34例患者（PB16；HP18）。与PB灌溉相比，HP冲洗导致平均肾内压力显着升高（平均（s.d.）62.29（27.45）与38.16（16.84）mmHg；平均值（MD）7.97至40.29mmHg的差异为95％c.i；P=0.005）和最大肾内压力（192.71（106.23）与68.04（24.16）mmHg；MD的95％c.i为70.76至178.59mmHg<0.001随着肾内压力的变化（对数转换）（6.23（1.59）对4.60（1.30）；MD为0.62至2.66的95％c.i；P=0.001）。与HP灌洗相比，PB对手术视力的满意度为10分（平均值（s.d.）8.75（0.58）比6.28（1.27）；MD为1.79至3.16的95％c.i；P<0.001）。主观HP使用力与传输的肾内压力没有显着相关（PearsonR=-0.15，P=0.57）。一名患者（HP组）出现尿脓毒症。
结论：与100-mmHgPB灌洗相比，手动HP灌洗导致肾内压力迹线更高，更波动（视觉清晰度较差）。
背景：osf.io/jmg2h(https://osf.io/)。
方法：一项平行随机试验招募了三家医院的患者。接受11/13-Fr输尿管入路鞘逆行肾内手术治疗肾结石的患者随机分配到100mmHg加压袋（PB）或手动泵（HP）冲洗。主要结果是平均程序肾内压力。次要结果包括最大肾内压力，方差，可视化,HP使用力,程序持续时间,石材间隙,和临床结果。使用COMETTMII压力导丝进行实时肾内压力监测，膀胱镜下部署到肾盂。操作团队对肾内压力视而不见。
结果：在2023年7月至11月之间随机分配了38例患者（试验结束）。最终分析包括34例患者（PB16；HP18）。与PB灌溉相比，HP冲洗导致平均肾内压力显着升高（平均（s.d.）62.29（27.45）与38.16（16.84）mmHg；平均值（MD）7.97至40.29mmHg的差异为95％c.i；P=0.005）和最大肾内压力（192.71（106.23）与68.04（24.16）mmHg；MD的95％c.i为70.76至178.59mmHg<0.001随着肾内压力的变化（对数转换）（6.23（1.59）对4.60（1.30）；MD为0.62至2.66的95％c.i；P=0.001）。与HP灌洗相比，PB对手术视力的满意度为10分（平均值（s.d.）8.75（0.58）比6.28（1.27）；MD为1.79至3.16的95％c.i；P<0.001）。主观HP使用力与传输的肾内压力没有显着相关（PearsonR=-0.15，P=0.57）。一名患者（HP组）出现尿脓毒症。
结论：与100-mmHgPB灌洗相比，手动HP灌洗导致肾内压力迹线更高，更波动（视觉清晰度较差）。
背景：osf.io/jmg2h(https://osf.io/)。
