• 文章类型: Journal Article
    探讨输尿管软镜(FURS)术中常规(网布+喷粉)和摩西(pop-dusting)钬激光治疗2~3cm肾结石的可行性,并比较两种方法的有效性和安全性,将230例2~3cm肾结石行FURS的患者随机分为常规组和摩西组。常规组的碎石方式为碎裂和除尘。摩西组的碎石方式是喷粉和喷粉。比较了两个队列之间的临床和围手术期变量以及并发症。对无结石率(SFR)和手术时间的影响因素进行了多因素分析。在人口统计学中没有发现统计学上的显着差异,肾结石相关数据,SFR,或队列之间的并发症。摩西队列的激光能量高于传统队列(119.3±15.2vs.92.8±15.1kJ;P<0.001),摩西队列的手术时间比常规队列短(99.5±18.9vs.105.3±13.7min;P=0.009)。当有孤立的石头时,摩西队列的手术时间比常规队列短(99.6±17.5vs.111.4±10.7分钟;P<0.001),而当存在多个结石时,两个队列之间没有显着差异(99.5±20vs.101.2±14分钟;P=0.415)。多因素分析发现,结石体积的增加可降低SFR,延长手术时间,使用摩西激光可以缩短手术时间。FURS期间的两种钬激光模式均可有效治疗2-3cm肾结石。建议将摩西模式作为治疗孤立的2-3厘米肾结石的首选。当治疗多个结石时,这两种激光模式的效率是相同的。试用注册:ChiCTR2200056091。
    To investigate the feasibility of conventional (basketing + dusting) and Moses (pop-dusting) holmium lasers during flexible ureteroscopy (FURS) in the treatment of 2-3 cm renal calculi and to compare the efficiency and safety of the two methods, a total of 230 patients with 2-3 cm kidney stones who underwent FURS were randomly divided into the conventional group and the Moses group. The mode of lithotripsy in the conventional group was fragmentation and dusting. The mode of lithotripsy in the Moses group was dusting and pop-dusting. Clinical and perioperative variables and complications were compared between the two cohorts. Multivariate analyses of factors contributing to the stone-free rate (SFR) and operation time were performed. No statistically significant differences were found in the demographics, renal stone-related data, SFR, or complications between the cohorts. The laser energy was higher in the Moses cohort than in the conventional cohort (119.3 ± 15.2 vs. 92.8 ± 15.1 kJ; P < 0.001), and the operation time was shorter in the Moses cohort than in the conventional cohort (99.5 ± 18.9 vs. 105.3 ± 13.7 min; P = 0.009). When there was isolated stone, the operation time was shorter in the Moses cohort than in the conventional cohort (99.6 ± 17.5 vs. 111.4 ± 10.7 min; P < 0.001), while there was no significant difference between the two cohorts when there were multiple stones (99.5 ± 20 vs. 101.2 ± 14 min; P = 0.415). Multivariate analyses found that an increase in stone volume can decrease the SFR and prolong the operation time, and use of a Moses laser can shorten the operation time. Both holmium laser modes during FURS can effectively treat 2-3 cm renal calculi. The Moses mode is recommended as the first choice for the treatment of isolated 2-3 cm renal stones. When treating multiple stones, the efficiency of these two laser modalities is the same. TRIAL REGISTRATION: ChiCTR2200056091.
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  • 文章类型: Journal Article
    目的:评估内镜下结石手术对儿童肾脏灌注和血流的影响。
    方法:接受经皮肾镜取石术(PCNL)的儿童,逆行肾内手术(RIRS),输尿管肾镜检查(URS),内镜联合肾内手术(ECIRS)纳入研究.术前1天进行肾多普勒超声检查(RDUS),术后第1天和第1个月。测量收缩期峰值速度(PSV)和舒张末期速度(EDV),电阻指数(RI)用(PSV-EDV)/PSV公式计算。比较手术前后以及同侧和对侧肾脏之间的RDUS参数。
    结果:共纳入45名中位年龄为8(2-17)岁的儿童(15名(33.3%)女孩,30名(66.7%)男孩)。13名儿童(28.9%)进行了PCNL,RIRS11(24.4%),URS12(26.7%),和ECIRS9(20%)。肾脏和节段性PSV无显著差异,术前肾脏的EDV和RI值,术后期间。在术前或术后期间,同侧和对侧肾脏的RDUS参数之间没有显着差异。术前未行DJ支架组术后第1个月的PSV和EDV值均明显高于有DJ支架组(分别为p=0.031,p=0.041)。然而,RI值相似。每个时期的平均RI低于阈值0.7。
    结论:RDUS参数在儿童中没有显着差异。在小儿结石疾病中可以安全地进行内窥镜手术。
    OBJECTIVE: To assess the impact of endoscopic stone surgeries on renal perfusion and blood flow in children.
    METHODS: Children who underwent percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), ureterorenoscopy (URS), endoscopic combined intrarenal surgery (ECIRS) were included to the study. Renal Doppler ultrasonography (RDUS) was performed one day before the operation, and on the postoperative 1st day and 1st month. Peak systolic velocity (PSV) and end-diastolic velocity (EDV) were measured, and resistive index (RI) was calculated with the (PSV-EDV)/PSV formula. RDUS parameters were compared before and after surgery and between ipsilateral and contralateral kidneys.
    RESULTS: A total of 45 children with a median age was 8 (2-17) years were included (15 (33.3%) girls, 30 (66.7%) boys). PCNL was performed in 13 children (28.9%), RIRS 11 (24.4%), URS 12 (26.7%), and ECIRS 9 (20%). There was no significant difference in renal and segmental PSV, EDV and RI values of operated kidney in the preoperative, postoperative periods. There was no significant difference between RDUS parameters of the ipsilateral and contralateral kidneys in preoperative or postoperative periods. PSV and EDV values were significantly higher in the 1st postoperative month in the group without preoperative DJ stent than in the group with DJ stent (p = 0,031, p = 0,041, respectively). However, RI values were similar. The mean RI were below the threshold value of 0.7 in each period.
    CONCLUSIONS: RDUS parameters didn\'t show a significant difference in children. Endoscopic surgeries can be safely performed in pediatric stone disease.
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  • 文章类型: Journal Article
    目的:预见性护理在输尿管镜取石术患者中已成为一种有希望的方法。因此,这项研究旨在通过在治疗和护理过程的早期对可能的风险进行预测性分析,加强个性化护理计划并降低并发症的风险。
    方法:收集了在2020年1月至2023年1月期间接受输尿管镜取石术的108例患者的临床数据。将患者分为对照组(常规护理,n=53)和观察组(预测性护理,n=55)根据护理方法,比较两组手术患者的各项临床指标。
    结果:两组的一般资料无明显差异(p>0.05)。与对照组相比,第一次排气(p<0.05),第一次下床(p<0.05),排石时间(p<0.05),观察组首次排便时间(p<0.05)和住院时间(p<0.05)均较短;术后1天,总体舒适度问卷(GCQ)各维度评分差异无统计学意义;术后2天,观察组各维度的GCQ评分均显著高于对照组(p<0.05)。观察组术后并发症发生率明显低于对照组(p<0.05)。
    结论:预见性护理能有效改善输尿管结石患者,加快术后恢复进程,减少并发症的发生;从而,这一过程值得临床广泛推广。
    OBJECTIVE: Predictive care in patients undergoing ureteroscopic stone surgery has emerged as a promising approach. Thus, this study aims to enhance personalised nursing plans and reduce the risk of complications by conducting predictive analysis of possible risks early in the treatment and nursing process.
    METHODS: Clinical data were collected from 108 patients who underwent ureteroscopic stone surgery and were admitted to our hospital between January 2020 and January 2023. Patients were divided into a control group (conventional nursing, n = 53) and an observation group (predictive care, n = 55) based on the nursing method, and various clinical indicators were compared between the two groups of surgical patients.
    RESULTS: No significant difference in general data was found between the two groups (p > 0.05). Compared with the control group, the first time to exhaust gas (p < 0.05), the first time to get out of bed (p < 0.05), the time to exhaust stone (p < 0.05), the first time to defecate (p < 0.05) and the length of hospital stay (p < 0.05) in the observation group were shorter; 1 day after surgery, no significant differences in all dimensions of the general comfort questionnaire (GCQ) score were found; 2 days after surgery, the GCQ score in all dimensions of the observation group was significantly higher than that of the control group (p < 0.05). The incidence of postoperative complications in the observation group was significantly lower than that in the control group (p < 0.05).
    CONCLUSIONS: Predictive nursing can effectively improve the patients with ureteral calculi, accelerate the process of postoperative recovery and reduce the occurrence of complications; Thus, this process is worthy of widespread clinical promotion.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    背景:丙泊酚是一种有效的常规麻醉药,用于输尿管镜检查的镇静麻醉(PSA)。然而,呼吸抑制和无意识的体力活动总是发生在基于丙泊酚的PSA,尤其是老年患者。Esketamine具有镇静和镇痛作用,但没有心肺抑制的风险。目的探讨艾氯胺酮能否降低老年男性患者输尿管镜成功置入的丙泊酚中位有效剂量(ED50)。
    方法:49例择期行输尿管硬镜的老年男性患者随机分为两组:SK组(0.25mg/kg艾氯胺酮+丙泊酚)和SF组(0.1µg/kg舒芬太尼+丙泊酚)。两组患者在静脉注射舒芬太尼或艾氯胺酮后,均接受丙泊酚,初始推注剂量为1.5mg/kg。通过改良的Dixon上下法评估异丙酚的有效剂量,然后根据先前的患者反应调整0.1mg/kg。患者对输尿管镜插入的反应被归类为“运动”或“无运动”。主要结果是异丙酚的ED50,用于成功插入esketamine或舒芬太尼的输尿管镜。次要结果是诱导时间,不良事件,如血液动力学变化,还测量了低氧血症和身体运动。
    结果:49名患者入选并完成了本研究。SK组成功插入输尿管镜的异丙酚ED50为1.356±0.11mg/kg,与SF组相比有所下降,1.442±0.08mg/kg(P=0.003)。SK组诱导时间明显短于SF组(P=0.001)。在SK集团,与SF组相比,观察到更稳定的血流动力学变量.两组间的不良事件发生率差异无统计学意义。
    结论:老年男性患者输尿管镜置入术应用异丙酚与艾氯胺酮的ED50为1.356±0.11mg/kg,与舒芬太尼相比,显着降低。
    背景:中国临床试验注册中心,编号:ChiCTR2300077170。2023年11月1日注册。预期注册。http://www。chictr.org.cn.
    BACKGROUND: Propofol is effective and used as a kind of routine anesthetics in procedure sedative anesthesia (PSA) for ureteroscopy. However, respiratory depression and unconscious physical activity always occur during propofol-based PSA, especially in elderly patients. Esketamine has sedative and analgesic effects but without risk of cardiorespiratory depression. The purpose of this study is to investigate whether esketamine can reduce the propofol median effective dose (ED50) for successful ureteroscope insertion in elderly male patients.
    METHODS: 49 elderly male patients undergoing elective rigid ureteroscopy were randomly divided into two groups: SK Group (0.25 mg/kg esketamine+propofol) and SF Group (0.1 µg/kg sufentanil+propofol). Patients in both two groups received propofol with initial bolus dose of 1.5 mg/kg after sufentanil or esketamine was administered intravenously. The effective dose of propofol was assessed by a modified Dixon\'s up-and-down method and then was adjusted with 0.1 mg/kg according to the previous patient response. Patients\' response to ureteroscope insertion was classified as \"movement\" or \"no movement\". The primary outcome was the ED50 of propofol for successful ureteroscope insertion with esketamine or sufentanil. The secondary outcomes were the induction time, adverse events such as hemodynamic changes, hypoxemia and body movement were also measured.
    RESULTS: 49 patients were enrolled and completed this study. The ED50 of propofol for successful ureteroscope insertion in SK Group was 1.356 ± 0.11 mg/kg, which was decreased compared with that in SF Group, 1.442 ± 0.08 mg/kg (P = 0.003). The induction time in SK Group was significantly shorter than in SF Group (P = 0.001). In SK Group, more stable hemodynamic variables were observed than in SF Group. The incidence of AEs between the two groups was not significantly different.
    CONCLUSIONS: The ED50 of propofol with esketamine administration for ureteroscope insertion in elderly male patients is 1.356 ± 0.11 mg/kg, significantly decreased in comparsion with sufentanil.
    BACKGROUND: Chinese Clinical Trial Registry, No: ChiCTR2300077170. Registered on 1 November 2023. Prospective registration. http://www.chictr.org.cn .
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  • 文章类型: Journal Article
    本研究旨在确定在输尿管结石碎石术中使用Thulium光纤激光器(TFL)的最佳参数,以确保激光安全并最大程度地提高疗效。我们的目标是改善一次性半刚性输尿管镜检查治疗输尿管近端结石的效果。设计了一种临床相关的热测试装置,以研究TFL结石破碎过程中的加热效应。该设备用于确定各种灌溉速率下TFL的安全功率阈值。其他三个设备用于评估不同的脉冲能量对碎石效率的影响。除尘,逆行,和组织汽化的深度。在新鲜的猪肾单元中进行了比较实验,以验证在近端输尿管结石手术中半刚性输尿管镜检查的最佳TFL参数的有效性和安全性。我们的研究发现,改进后的器件产生了更高的热效应。此外,激光碎石的安全功率阈值随着灌水率的提高而提高。在40毫升/分钟的冲洗速率下,使用低于30瓦的平均功率是安全的。尽管增加脉冲能量对碎裂和除尘效率的影响逐渐降低,它确实导致结石位移和组织汽化深度线性增加。热测试显示20W(53.87±2.67°C)表明潜在的尿路上皮损伤。在我们对输尿管近端结石的激光碎石术的研究中,与0.8J组相比,用0.3J脉冲治疗的组有几个优点:较大的碎片较少(>4mm):0vs.1.67片段(1-2.25),p=0.002,侧支组织损伤的数量较低:0.50(0-1.25)与2.67(2-4),p=0.011,下结石逆行分级:0.83(0.75-1)vs.1.67(1-2),p=0.046。两组手术时间差异无统计学意义(443.33±78.30svs.463.17±75.15s,p=0.664)。这些发现表明,与未辐照的结石相比,TFL辐照会产生更大的热效应。此外,激光碎石术中的热效应受功率和冲洗流量的影响。我们的研究表明,使用低于15W的功率和20ml/min的冲洗流量是安全的。此外,0.3J的脉冲能量似乎是实现最佳整体碎石效果的最佳选择。
    This study aims to identify optimal parameters for using Thulium fiber lasers (TFL) in ureteral stone lithotripsy to ensure laser safety and maximize efficacy. Our goal is to improve the outcomes of single-use semi-rigid ureteroscopy for treating stones located in the proximal ureter. A clinically relevant thermal testing device was designed to investigate heating effects during TFL stone fragmentation. The device was utilized to identify safe power thresholds for TFL at various irrigation rates. Three other devices were used to assess varying pulse energy effects on stone fragmentation efficiency, dusting, retropulsion, and depth of tissue vaporization. Comparative experiments in fresh porcine renal units were performed to validate the efficacy and safety of optimal TFL parameters for semi-rigid ureteroscopy in proximal ureteral stone procedures. Our study found that the improved device generated a higher thermal effect. Furthermore, the safe power threshold for laser lithotripsy increased as the irrigation rate was raised. At an irrigation rate of 40 ml/min, it is safe to use an average power of less than 30 watts. Although increasing pulse energy has a progressively lower effect on fragmentation and dust removal efficiency, it did lead to a linear increase in stone displacement and tissue vaporization depth. Thermal testing showed 20 W (53.87 ± 2.67 °C) indicating potential urothelial damage. In our study of laser lithotripsy for proximal ureteral stones, the group treated with 0.3 J pulses had several advantages compared to the 0.8 J group: Fewer large fragments (> 4 mm): 0 vs. 1.67 fragments (1-2.25), p = 0.002, a lower number of collateral tissue injuries: 0.50 (0-1.25) vs. 2.67 (2-4), p = 0.011, and lower stone retropulsion grading: 0.83 (0.75-1) vs. 1.67 (1-2), p = 0.046. There was no significant difference in operating time between the groups (443.33 ± 78.30 s vs. 463.17 ± 75.15 s, p = 0.664). These findings suggest that TFL irradiation generates a greater thermal effect compared to non-irradiated stones. Furthermore, the thermal effect during laser lithotripsy is influenced by both power and irrigation flow rate. Our study suggests that using a power below 15 W with an irrigation flow rate of 20 ml/min is safe. Moreover, a pulse energy of 0.3 J appears to be optimal for achieving the best overall stone fragmentation effect.
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  • 文章类型: Journal Article
    目的:比较钬激光碎石术与体外冲击碎石术(SWL)对SWL后输尿管蒸汽碎石术的疗效。
    方法:自2022年1月至2023年7月,将36例SWL后输尿管结石患者随机分为激光碎石组和SWL组。疼痛患者,中度至显著肾积水,大的主要石头碎片,并显示在药物治疗后3-4周内无自发消退。排除脓毒症患者。成功率是主要结果。我们比较了组间的围手术期数据。
    结果:输尿管镜组的成功率高于SWL组(p=0.034)。SWL是一个明显更长的手术,SWL组的透视时间明显长于URS组(p=0.027).与URS组相比,SWL组的辅助手术频率更高(p=0.02)。在URS组中100%的患者中插入JJ支架。在第二次SWL治疗失败后,三名患者(16.7%)接受了激光输尿管镜检查。术后并发症发生率组间差异无统计学意义,但输尿管镜组术后LUT的发生率较高.输尿管镜组的平均住院时间为30小时。在不需要入院的情况下进行SWL。
    结论:输尿管镜下激光碎石术是安全有效的,成功率更高,更短的透视时间,恢复期比SWL短。
    OBJECTIVE: To compare the efficacy of Holmium laser lithotripsy with that of extracorporeal shock lithotripsy (SWL) for post-SWL ureteral steinstrasse.
    METHODS: From January 2022 to July 2023, 36 patients with post-SWL ureteral steinstrasse were randomly divided into laser lithotripsy and SWL groups. Patients with pain, moderate to marked hydronephrosis, large leading stone fragments, and showing no spontaneous resolution within 3-4 weeks after medical expulsive therapy were included. Patients with sepsis were excluded. The success rate was the primary outcome. We compared the perioperative data between the groups.
    RESULTS: The success rate was higher in the ureteroscopy group than in the SWL group (p = 0.034). SWL was a significantly longer operation, and the fluoroscopy time was significantly longer in the SWL group than in the URS group (p = 0.027). Auxiliary procedures were more frequently performed in the SWL group than in the URS group (p = 0.02). JJ stents were inserted in 100% of patients in the URS group. Three patients (16.7%) underwent conversion to laser ureteroscopy after the second SWL session failed. No significant difference in the incidence of postoperative complications was observed between the groups, but the incidence of postoperative LUT was high in the ureteroscopy group. The mean hospital stay was 30 h in the ureteroscopy group. SWL was performed without the need for hospital admission.
    CONCLUSIONS: Ureteroscopic laser lithotripsy for steinstrasse was safe and effective, with a higher success rate, shorter fluoroscopy time, and shorter recovery period than SWL.
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  • 文章类型: Journal Article
    目的:探讨智能控制肾盂压力(RPP)的输尿管软镜术中液体吸收及其影响因素。
    方法:对80例上尿路结石患者进行输尿管软镜检查,通过测量输尿管入路鞘管对RPP进行智能控制,随机分为4组。A组的RPP,B,C设定为-5、0和5mmHg,分别。常规输尿管软镜不受控制的压力作为对照组。D.四组灌注流速设定为100ml/min。每组20名患者。每10分钟通过1%乙醇测量流体吸收。操作时间,无石率,并记录并发症。
    结果:73例患者最终纳入RCT。两组患者的一般资料和术前资料具有可比性。A组的流体吸收,B,C组明显少于D组(P<0.01)。吸液量与手术时间呈正相关,相关系数R分别为0.864、0.896、0.918、0.947(P<0.01)。呕吐患者的液体吸收,四组患者发热和输尿管损伤均大于无并发症患者(P<0.01)。在不同的群体中,输尿管损伤后病变评分(PULS)1~3级患者的液体吸收高于未损伤患者(P<0.01)。
    结论:输尿管软镜联合智能控制RPP可有效减少灌注液的吸收。手术时间和输尿管损伤也是影响灌注液吸收的关键因素。
    NCT05201599;2021年8月11日。
    OBJECTIVE: To investigate fluid absorption and its influencing factors during flexible ureteroscopy with intelligent control of renal pelvic pressure (RPP).
    METHODS: A total of 80 patients with upper urinary tract calculi underwent flexible ureteroscopy with intelligent control of RPP by pressure-measuring ureteral access sheath and were randomly divided into four groups. The RPP of Groups A, B, and C were set at - 5, 0 and 5 mmHg, respectively. Conventional flexible ureteroscopy with uncontrolled pressure served as control Group D. The perfusion flow rate was set at 100 ml/min in the four groups, with 20 patients in each group. The fluid absorption was measured by 1% ethanol every 10 min. Operation time, stone-free rate, and complications were recorded.
    RESULTS: Seventy-three patients were finally included in the RCT. The general and preoperative data of the patients were comparable between the groups. The fluid absorption of Groups A, B, and C was significantly less than that of Group D (P < 0.01). Fluid absorption and operation time were positively correlated, and the correlation coefficients R were 0.864, 0.896, 0.918, and 0.947, respectively (P < 0.01). The fluid absorption of patients with vomiting, fever and ureteral injury was greater than that of patients without complications in the four groups (P < 0.01). In different groups, fluid absorption was greater in patients with ureteral injury Post-Ureteroscopic Lesion Scale (PULS) 1-3 than in noninjured patients (P < 0.01).
    CONCLUSIONS: Flexible ureteroscopy with intelligent control of RPP effectively reduces the absorption of perfusion fluid. Operation time and ureteral injury are also key factors affecting perfusion fluid absorption.
    UNASSIGNED: NCT05201599; August 11, 2021.
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  • 文章类型: Journal Article
    目的:本研究的目的是评估在术前URS同意过程中使用视频-同意可能的有益效果。
    方法:前瞻性随机试验于2022年3月至2022年9月在意大利的两个三级医疗中心进行。患者被随机分为两组:A组(标准口头/书面知情同意书)和B组(视频支持的知情同意书)。我们调查了两种类型的知情同意对术前和术后用STAI问卷评估的患者焦虑水平的影响。此外,我们评估了知情同意对术后疼痛的影响,用VAS量表测量,以及住院期间求助次数作为次要结果。评估与整个过程相关的满意度,我们要求患者以1-10的等级对他们的经历进行评分,其中1表示“不满意”,10表示“完全满意”。\"
    结果:总体而言,每组166例患者以1:1随机分组。根据多元回归模型,视频辅助知情同意书显著增加了术后与术前STAI之间的差异,降低焦虑程度。视频辅助知情同意书可显著预测住院期间的援助电话数量。
    结论:输尿管镜检查的视频同意是提高患者满意度和对手术意识的有效工具。视频同意能够减少患者在术后期间与手术和援助电话相关的焦虑,从而产生一个有用的工具来管理一个更好的知情同意书。
    Purpose: The aim of this study is to evaluate the possible benefits of using video consent in the preoperative ureteroscopy (URS) consent process. Material and Methods: Prospective randomized trials took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of informed consent on patient anxiety levels using the Spielberger State-Trait Anxiety Inventory (STAI) questionnaire both pre- and post-consent. In addition, using the Visual Analogue Scale, analysis of the effect of informed consent on postoperative pain and the number of calls for assistance during hospitalization as secondary outcomes was done. To assess the satisfaction level related to the whole process, patients were asked to rate their experience on a scale of 1-10, with 1 indicating \"not satisfied\" and 10 indicating \"completely satisfied.\" Results: Overall, 166 patients were randomized 1:1 in each group. The multivariable regression model demonstrated that video-assisted informed consent significantly increased the difference between post- and pre-consent STAI with a reduced level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during hospitalization. Conclusions: Video consent for ureteroscopies is a valid tool to improve procedure awareness and satisfaction. Video consent is able to reduce procedure-related patient anxiety and postoperative assistance calls, thus proving to be useful in obtaining better-informed consent for endourological procedures.
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  • 文章类型: Journal Article
    背景:Sotn输尿管镜检查是在输尿管镜检查的基础上开发的一种新的碎石术,包括刚性输尿管入路鞘,标准镜子,碎石镜,和Sotn灌注抽吸器。因此,我们进行了一项前瞻性多中心随机对照试验,比较了Sotn输尿管镜治疗肾结石和输尿管上段结石的安全性和有效性.
    方法:在本研究中,选取2018年3月至2022年3月224例肾结石和输尿管上段结石患者,随机均分为研究组和对照组。所有患者均获得中国广州中医药大学第二附属医院医院伦理委员会批准(证明编号:ZF-2018-164-01和ZF-2018-165-01)。主要结果是治疗后第1天和第1个月通过计算机断层扫描评估的结石发生率(SFR)以及手术时间。次要结果是术后并发症发生率。
    结果:总计,输尿管上段结石,Sotn输尿管镜组术后1天的SFR明显高于刚性输尿管镜组(83.6%vs.60%,P=0.006)。此外,手术时间(33.7±1.80vs.52.9±2.73min,Sotn输尿管镜组的P<0.005)明显低于刚性输尿管镜组。此外,研究组(Sotn输尿管镜联合输尿管软镜)和对照组(单纯输尿管软镜)术后1天SFR分别为63.2%和36.8%(P=0.005),65.6±4.06和80.3±4.91(P=0.023),分别。然而,术后1个月SFR无显著性差异,输尿管入路鞘放置成功率,两组术后并发症发生率比较(P>0.05)。在结石直径≥1.5cm且结石CT值≥1000Hounsfield单位的亚组中,Sotn输尿管镜在术后1天的SFR方面显示出更多优势。重要的是,并发症,如输尿管损伤,脓毒症,发烧,两组血尿和重度血尿比较差异无统计学意义(P>0.05)。
    结论:对于肾和输尿管上段结石,Sotn输尿管镜具有术后1天SFR较高、手术时间较短的优点,这表明Sotn输尿管镜检查可能在临床上有进一步的潜在应用。
    BACKGROUND: Sotn ureteroscopy is a new lithotripsy procedure developed on the basis of ureteroscopy and includes a rigid ureteral access sheath, standard mirror, lithotripsy mirror, and Sotn perfusion aspirator. Thus, we performed a prospective multicenter randomized controlled trial comparing the safety and efficacy of Sotn ureteroscopy in the treatment of renal and upper ureteral calculi.
    METHODS: In this study, 224 patients with renal and upper ureteral calculi were randomly divided equally into study and control groups from March 2018 to March 2022. All the patients were approved by the hospital ethics committee (proof number: ZF-2018-164-01 and ZF-2018-165-01) of the Second Affiliate Hospital of Guangzhou University of Chinese Medicine in China. The primary outcome was stone-free rate (SFR) assessed by computed tomography on the 1st day and month after treatment and operation duration. The secondary outcome was postoperative complication rate.
    RESULTS: In total, for upper ureteral calculi, the SFR of 1 day after operation of the Sotn ureteroscopy group was significantly higher than the rigid ureteroscopy group (83.6% vs. 60%, P=0.006). Moreover, operative time (33.7±1.80 vs. 52.9±2.73 min, P<0.005) of the Sotn ureteroscopy group was significantly lower than the rigid ureteroscopy group. Additionally, the SFR of 1 day after operation and operative time for the study group (Sotn ureteroscopy combined with flexible ureteroscopy) and the control group (flexible ureteroscopy alone) were 63.2% and 36.8% (P=0.005), 65.6±4.06 and 80.3±4.91 (P=0.023), respectively. However, there were no significant differences in the SFR of 1 month after operation, success rate of ureteral access sheath placement, and postoperative complications between the two groups (P>0.05). In subgroups with stone diameters ≥1.5 cm and stone CT values ≥1000 Hounsfield units, Sotn ureteroscopy showed more advantages in terms of the SFR of 1 day after operation. Importantly, complications such as ureteral injury, sepsis, fever, and severe hematuria were not statistically different between the two groups (P>0.05).
    CONCLUSIONS: For renal and upper ureteral calculi, Sotn ureteroscopy has the advantage of a higher SFR of 1 day after the operation and a shorter operative time, suggesting that the Sotn ureteroscopy may have further potential applications in clinics.
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