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预防性使用补片预防回肠造口旁疝的随机研究。

Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study.

机构信息

Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.

Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.

出版信息

Eur Urol. 2020 Nov;78(5):757-763. doi: 10.1016/j.eururo.2020.07.033. Epub 2020 Aug 13.

Abstract

BACKGROUND

Parastomal hernia (PSH) after urinary diversion with ileal conduit is frequently a clinical problem.

OBJECTIVE

To investigate whether a prophylactic lightweight mesh in the sublay position can reduce the cumulative incidence of PSH after open cystectomy with ileal conduit.

DESIGN, SETTING, AND PARTICIPANTS: From 2012 to 2017, we randomised 242 patients 1:1 to conventional stoma construction (n = 124) or prophylactic mesh (n = 118) at three Swedish hospitals (ISRCTN 95093825).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary endpoint was clinical PSH, and secondary endpoints were radiological PSH assessed in prone position with the stoma in the centre of a ring, parastomal bulging, and complications from the mesh.

RESULTS AND LIMITATIONS

Within 24 mo, 20/89 (23%) patients in the control arm and 10/92 (11%) in the intervention arm had developed a clinical PSH (p = 0.06) after a median follow-up of 3 yr, corresponding to a hazard ratio of 0.45 (confidence interval 0.24-0.86, p = 0.02) in the intervention arm. The proportions of radiological PSHs within 24 mo were 22/89 (25%) and 17/92 (19%) in the two study arms. During follow-up, five patients in the control arm and two in the intervention arm were operated for PSH. The median operating time was 50 min longer in patients receiving a mesh. No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.

CONCLUSIONS

Prophylactic implantation of a lightweight mesh in the sublay position decreases the risk of PSH when constructing an ileal conduit without increasing the risk of complications related to the mesh. The median surgical time is prolonged by mesh implantation.

PATIENT SUMMARY

In this randomised report, we looked at the risk of parastomal hernia after cystectomy and urinary diversion with ileal conduit with or without the use of a prophylactic mesh. We conclude that such a prophylactic measure decreased the occurrence of parastomal hernias, with only a slight increase in operating time and no added risk of complications related to the mesh.

摘要

背景

尿流改道术(UC)后发生的造口旁疝(PSH)是一种常见的临床问题。

目的

探讨在开放膀胱切除术加回肠导管造口术中预防性放置下腹膜下轻质网片是否能降低 PSH 的累积发生率。

设计、地点和参与者:2012 年至 2017 年,我们在瑞典的三家医院(ISRCTN 95093825)将 242 名患者按 1:1 随机分为常规造口术(n=124)或预防性网片组(n=118)。

结局测量和统计分析

主要结局是临床 PSH,次要结局是在俯卧位时用位于造口中央的环形物评估的放射学 PSH、造口旁膨出和网片相关并发症。

结果和局限性

在 24 个月内,对照组 89 例中有 20 例(23%)和干预组 92 例中有 10 例(11%)发生临床 PSH(p=0.06),中位随访 3 年后,干预组的危险比为 0.45(24%置信区间 0.24-0.86,p=0.02)。在 24 个月内,两组的放射学 PSH 比例分别为 22/89(25%)和 17/92(19%)。在随访期间,对照组中有 5 例和干预组中有 2 例患者因 PSH 而行手术治疗。接受网片治疗的患者的中位手术时间延长了 50 分钟。两组在术后 90 天的 Clavien-Dindo 并发症比例或随访期间与网片相关的并发症方面均无差异。

结论

在构建回肠导管造口术时预防性放置下腹膜下轻质网片可降低 PSH 的风险,而不会增加与网片相关的并发症的风险。网片植入会延长手术时间的中位数。

患者总结

在这项随机报告中,我们研究了在进行膀胱切除术和回肠导管造口术时使用或不使用预防性网片与发生造口旁疝的风险。我们的结论是,这种预防性措施降低了造口旁疝的发生,仅略微增加了手术时间,且与网片相关的并发症风险没有增加。

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