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通过最小化支架材料减少支架相关并发症:一项前瞻性、随机、单盲优效性试验,评估一种定制的“缝合支架”。

Reduction of stent-associated morbidity by minimizing stent material: a prospective, randomized, single-blind superiority trial assessing a customized 'suture stent'.

机构信息

Department of Urology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.

Biostatistics, Clinical Trials Unit, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.

出版信息

BJU Int. 2021 May;127(5):596-605. doi: 10.1111/bju.15290. Epub 2020 Dec 15.

DOI:10.1111/bju.15290
PMID:33152169
Abstract

OBJECTIVES

To compare a customized 'suture stent' with a standard ureteric stent regarding stent-related symptoms, safety and efficacy.

MATERIALS AND METHODS

Patients with urolithiasis located proximal to the iliac vessel crossing, requiring stenting in preparation for secondary ureterorenoscopy (URS) were randomized to standard ureteric stenting or a suture stent. Secondary ureterorenoscopy was performed 2-6 weeks later. The Ureteral Stent Symptoms Questionnaire (USSQ) was completed after 1 week, on the day before URS and 2-6 weeks after stent removal. Stent efficacy and safety were systematically assessed.

RESULTS

A total of 88 patients were included in the analysis. The median (range) suture stent length was 10 (5-25) cm vs 26 cm for standard stents. Operation time was longer for insertion of the suture stent (24.0 vs 14.5 min; P < 0.001). Patients with a suture stent had a significantly lower USSQ urinary symptoms score 1 week after stent insertion, adjusted for baseline symptoms by subtracting scores from the final visit without indwelling stent (mean 7.1 vs 13.7, difference -6.6, 95% confidence interval [CI] -3.4 to -9.8; P < 0.001). Prior to secondary URS (after 2-6 weeks), baseline-adjusted urinary symptoms (mean 4.7 vs 12.2, difference -7.5, 95% CI -4.5 to -10.4; P < 0.001) and pain subscores (11.5 vs 17.6, difference -6.1, 95% CI -0.7 to -11.6; P = 0.004) were significantly lower in the suture stent group. All other USSQ subscores showed no significant differences. Adverse events occurred in 15 patients and were similarly frequent in the two groups. No significant differences were found between the groups regarding ureteric access during secondary URS.

CONCLUSION

Replacement of the distal part of ureteric stents by a suture can reduce stent-associated symptoms without restrictions regarding secondary stone removal or safety.

摘要

目的

比较定制的“缝线支架”与标准输尿管支架在支架相关症状、安全性和疗效方面的差异。

材料和方法

患有髂血管交叉处近端尿路结石、需要支架置入以准备进行二次输尿管镜检查(URS)的患者被随机分配至标准输尿管支架组或缝线支架组。2-6 周后进行二次输尿管镜检查。在 1 周后、URS 前 1 天和支架取出后 2-6 周时,使用输尿管支架症状问卷(USSQ)进行评估。系统评估支架的有效性和安全性。

结果

共有 88 例患者纳入分析。缝线支架的中位(范围)长度为 10(5-25)cm,标准支架的长度为 26cm。插入缝线支架的手术时间较长(24.0 分钟比 14.5 分钟;P<0.001)。与基线症状相比,支架置入 1 周后,缝线支架组的 USSQ 尿症状评分显著降低(差值-6.6,95%置信区间[CI] -3.4 至 -9.8;P<0.001)。在二次 URS 前(2-6 周后),基线校正后的尿症状(差值-7.5,95%CI -4.5 至 -10.4;P<0.001)和疼痛亚评分(差值-6.1,95%CI -0.7 至 -11.6;P=0.004)均显著低于缝线支架组。所有其他 USSQ 亚评分均无显著差异。两组均有 15 例患者发生不良事件,发生率相似。两组在二次 URS 时输尿管入路方面无显著差异。

结论

用缝线代替输尿管支架的远端部分可以减轻支架相关症状,而不会限制结石的二次取出或安全性。

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