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输尿管镜逆行取石术后短暂支架置入与无管化处理的前瞻性随机对照研究(Fast Track Stent 研究 2)

Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.

机构信息

Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.

Uroviva Klinik AG, Bülach, Switzerland.

出版信息

Int J Urol. 2020 Sep;27(9):749-754. doi: 10.1111/iju.14291. Epub 2020 Jul 6.

Abstract

OBJECTIVES

To determine whether in pre-stented patients undergoing ureteroscopic stone removal (ureteroscopy retrograde surgery) a tubeless procedure provides a better outcome compared with short-term (6 h) ureteral stenting using an external ureteral catheter.

METHODS

In this single academic center study (Fast Track Stent study 2), carried out between May 2016 and April 2018, 121 patients with renal or ureteral calculi were initially treated with double-J insertion. Before secondary ureteroscopy retrograde surgery, patients were prospectively randomized into two groups: tubeless versus ureteral catheter insertion for 6 h after ureteroscopy retrograde surgery. Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25 mm. Study end-points were stent-related symptoms assessed by a validated questionnaire (ureteral stent symptom questionnaire), administered both before and 4 weeks after surgery. Numerical ureteral stent symptom questionnaire scores were compared using the Mann-Whitney-U-test. The level of significance was defined as P < 0.05.

RESULTS

Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37). Patient groups did not differ significantly in their ureteral stent symptom questionnaire scores (urinary index P = 0.24; pain index P = 0.35). Patients showed a significant preference for tubeless procedure over ureteral catheter reinsertion (Question GQ P < 0.0001). The reintervention rate was 13.3% for the tubeless procedure (n = 8) and 1.6% for the ureteral catheter group (n = 1), respectively (P = 0.034).

CONCLUSIONS

Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction in pre-stented patients result in comparable quality of life. However, the reintervention rate is higher for tubeless procedures.

摘要

目的

确定在接受输尿管镜碎石取石术(逆行输尿管镜手术)的支架置入前患者中,与使用外部输尿管导管进行 6 小时短期输尿管支架置入相比,无管化操作是否能提供更好的结果。

方法

在这项 2016 年 5 月至 2018 年 4 月期间在单一家学术中心进行的前瞻性、随机对照研究(Fast Track Stent study 2)中,121 例肾结石或输尿管结石患者最初接受双 J 管置入。在二次逆行输尿管镜手术后,患者前瞻性随机分为两组:无管化组和输尿管导管组,在逆行输尿管镜手术后插入输尿管导管 6 小时。排除标准为急性尿路感染、孤立肾或结石直径>25mm。研究终点是通过验证后的问卷(输尿管支架症状问卷)评估支架相关症状,分别在术前和术后 4 周进行。使用 Mann-Whitney-U 检验比较数字输尿管支架症状问卷评分。显著性水平定义为 P<0.05。

结果

由 13 名外科医生进行的逆行输尿管镜手术程序在所有患者(n=121)中均实现了>90%的结石清除率,输尿管导管组和无管化组的平均手术时间分别为 19.9 分钟和 18.0 分钟(P=0.37)。两组患者的输尿管支架症状问卷评分无显著差异(尿指数 P=0.24;疼痛指数 P=0.35)。患者对无管化操作明显优于输尿管导管再插入(问题 GQ P<0.0001)。无管化组的再干预率为 13.3%(n=8),输尿管导管组为 1.6%(n=1)(P=0.034)。

结论

在支架置入前患者中,逆行输尿管镜手术后短期使用输尿管导管和不置入支架与生活质量相当。然而,无管化操作的再干预率更高。

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