Strategic Academic Recruitment (StAR) Programme, Royal College of Surgeons in Ireland, Dublin, Ireland.
Department of Urology, Blackrock Clinic, Dublin, Ireland.
Br J Surg. 2024 Jun 12;111(6). doi: 10.1093/bjs/znae137.
The aim was to ascertain the impact of irrigation technique on human intrarenal pressure during retrograde intrarenal surgery.
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.
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.
Manual HP irrigation resulted in higher and more fluctuant intrarenal pressure trace (with inferior visual clarity) than 100-mmHg PB irrigation.
osf.io/jmg2h (https://osf.io/).
本研究旨在确定逆行肾盂内手术中灌洗技术对人体肾盂内压的影响。
一项平行随机试验在三个医院招募了患者。接受逆行肾盂内手术治疗肾结石的患者，使用 11/13Fr 输尿管接入鞘，随机分配至 100mmHg 加压袋（PB）或手动手泵（HP）灌洗组。主要结局为手术中肾盂内的平均压力。次要结局包括肾盂内压力的最大值、变化幅度、可视化效果、HP 使用力度、手术时间、结石清除率和临床结局。使用 COMETTMII 压力导丝在膀胱镜下部署到肾盂，进行实时肾盂内压力监测。手术团队对肾盂内压力进行盲法操作。
2023 年 7 月至 11 月期间，共有 38 名患者进行了随机分组（试验关闭）。最终分析纳入 34 名患者（PB 组 16 名；HP 组 18 名）。与 PB 灌洗相比，HP 灌洗导致肾盂内压力显著升高（平均（标准差）：62.29（27.45）mmHg 比 38.16（16.84）mmHg；差值的 95%置信区间（CI）为 7.97 至 40.29mmHg；P=0.005）和肾盂内压力的最大值（192.71（106.23）mmHg 比 68.04（24.16）mmHg；差值的 95%CI 为 70.76 至 178.59mmHg；P<0.001），同时肾盂内压力变化幅度更大（对数转换）（6.23（1.59）mmHg 比 4.60（1.30）mmHg；差值的 95%CI 为 0.62 至 2.66mmHg；P=0.001）。根据 10 分制对手术中视野清晰度进行评分，PB 组比 HP 组的手术医生满意度更高（平均（标准差）：8.75（0.58）分比 6.28（1.27）分；差值的 95%CI 为 1.79 至 3.16 分；P<0.001）。主观 HP 使用力度与传递的肾盂内压力无显著相关性（Pearson R=-0.15，P=0.57）。1 名患者（HP 组）发生菌血症。
与 100mmHg PB 灌洗相比，手动 HP 灌洗导致肾盂内压力升高且波动更大（视觉清晰度降低）。
osf.io/jmg2h（https://osf.io/）。
Zotero 插件