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系统评价随机对照试验评估网片固定在开放式腹股沟疝修补术中的应用。

A systematic review of randomised control trials assessing mesh fixation in open inguinal hernia repair.

机构信息

Department of Upper GI Surgery, Royal Cornwall Hospital, Treliske, Truro, TR1 3LJ, UK,

出版信息

Hernia. 2014 Apr;18(2):165-76. doi: 10.1007/s10029-013-1093-8. Epub 2013 May 7.

Abstract

PURPOSE

The technique for fixation of mesh has been attributed to adverse patient and surgical outcomes. Although this has been the subject of vigorous debate in laparoscopic hernia repair, the several methods of fixation in open, anterior inguinal hernia repair have seldom been reviewed. The aim of this systematic review was to determine whether there is any difference in patient-based (recurrence, post-operative pain, SSI, quality of life) or surgical outcomes (operative time, length of operative stay) with different fixation methods in open anterior inguinal hernioplasty.

METHODS

A literature search was performed in PubMed, EMBASE and the Cochrane Library databases. Randomised clinical trials assessing more than one method of mesh fixation (or fixation versus no fixation) of mesh in adults (>18 years) in open, anterior inguinal hernia repair, with a minimum of 6-month follow-up and including at least one of the primary outcome measures (recurrence, chronic pain, surgical site infection) were included in the review. Secondary outcomes analysed included post-operative pain (within the first week), quality of life, operative time and length of hospital stay.

RESULTS

Twelve randomised clinical trials, which included 1,992 primary inguinal hernia repairs, were eligible for inclusion. Four studies compared n-butyl-2 cyanoacrylate (NB2C) glues to sutures, two compared self-fixing meshes to sutures, four compared fibrin sealant to sutures, one compared tacks to sutures, and one compared absorbable sutures to non-absorbable sutures. The majority of the trials were rated as low or very low-quality studies. There was no significant difference in recurrence or surgical site infection rates between fixation methods. There was significant heterogeneity in the measurement of chronic pain. Three trials reported significantly lower rates of chronic pain with fibrin sealant or glue fixation compared to sutures. A further three studies reported lower pain rates within the first week with non-suture fixation techniques compared to suture fixation. A significant reduction in operative time, ranging form 6 to 17.9 min with non-suture fixation, was reported in five of the studies. Although infrequently measured, there were no significant differences in length of hospital stay or quality of life between fixation methods.

CONCLUSIONS

There is insufficient evidence to promote fibrin sealant, self-fixing meshes or NB2C glues ahead of suture fixation. However, these products have been shown to be at least substantially equivalent, and moderate-quality RCTs have suggested that both fibrin sealant and NB2C glues may have a beneficial effect on reducing immediate post-operative pain and chronic pain in at-risk populations, such as younger active patients. It will ultimately be up to surgeons and health-care policy makers to decide whether based on the limited evidence these products represent a worthwhile cost for their patients.

摘要

目的

网片固定技术与患者和手术结果不良有关。尽管腹腔镜疝修补术对此进行了激烈的争论,但开放式前腹股沟疝修补术中的几种固定方法很少被回顾。本系统评价的目的是确定在开放式前腹股沟疝修补术中,不同的固定方法在基于患者的(复发、术后疼痛、SSI、生活质量)或手术结果(手术时间、住院时间)方面是否存在差异。

方法

在 PubMed、EMBASE 和 Cochrane 图书馆数据库中进行文献检索。纳入了评估成年人(>18 岁)开放式前腹股沟疝修补术中超过一种网片固定方法(或固定与不固定)的随机临床试验,随访时间至少 6 个月,并至少包括以下主要结局指标之一(复发、慢性疼痛、手术部位感染)。分析的次要结局包括术后疼痛(术后一周内)、生活质量、手术时间和住院时间。

结果

12 项随机临床试验,共纳入 1992 例原发性腹股沟疝修补术,符合纳入标准。四项研究比较了 n-丁基-2-氰基丙烯酸酯(NB2C)胶与缝线,两项研究比较了自固定网片与缝线,四项研究比较了纤维蛋白胶与缝线,一项研究比较了缝合钉与缝线,一项研究比较了可吸收缝线与不可吸收缝线。大多数试验被评为低质量或极低质量研究。固定方法之间在复发率或手术部位感染率方面无显著差异。慢性疼痛的测量存在显著的异质性。三项研究报告称,与缝线固定相比,纤维蛋白胶或胶固定的慢性疼痛发生率显著降低。另外三项研究报告称,与缝线固定相比,非缝线固定技术在术后第一周内疼痛发生率较低。五项研究报告称,与缝线固定相比,非缝线固定可显著缩短手术时间,范围为 6 至 17.9 分钟。尽管很少测量,但固定方法之间的住院时间或生活质量没有显著差异。

结论

没有足够的证据支持纤维蛋白胶、自固定网片或 NB2C 胶优于缝线固定。然而,这些产品已被证明至少在实质上是等效的,并且中等质量的 RCT 表明,纤维蛋白胶和 NB2C 胶都可能对减少高危人群(如年轻活跃的患者)的术后即刻疼痛和慢性疼痛有有益的影响。最终,这将取决于外科医生和卫生保健政策制定者,根据有限的证据,他们的患者是否认为这些产品的成本是值得的。

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