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腹股沟疝修补术中低成本补片的随机试验。

A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair.

机构信息

From the Department of Public Health and Clinical Medicine, Unit of Research, Education, and Development, Östersund, Umeå University, Umeå (J.L., P.N.), and the Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm (A.W.) - both in Sweden; and the Schools of Biomedical Sciences (C.I.) and Medicine (A.M.), Makerere University, and the Mulago National Referral Hospital (C.I.), Kampala, and the School of Public Health, Iganga-Mayuge Health and Demographic Surveillance Site, Iganga (E.G.) - all in Uganda.

出版信息

N Engl J Med. 2016 Jan 14;374(2):146-53. doi: 10.1056/NEJMoa1505126.

DOI:10.1056/NEJMoa1505126
PMID:26760085
Abstract

BACKGROUND

The most effective method for repair of a groin hernia involves the use of a synthetic mesh, but this type of mesh is unaffordable for many patients in low- and middle-income countries. Sterilized mosquito meshes have been used as a lower-cost alternative but have not been rigorously studied.

METHODS

We performed a double-blind, randomized, controlled trial comparing low-cost mesh with commercial mesh (both lightweight) for the repair of a groin hernia in adult men in eastern Uganda who had primary, unilateral, reducible groin hernias. Surgery was performed by four qualified surgeons. The primary outcomes were hernia recurrence at 1 year and postoperative complications.

RESULTS

A total of 302 patients were included in the study. The follow-up rate was 97.3% after 2 weeks and 95.6% after 1 year. Hernia recurred in 1 patient (0.7%) assigned to the low-cost mesh and in no patients assigned to the commercial mesh (absolute risk difference, 0.7 percentage points; 95% confidence interval [CI], -1.2 to 2.6; P=1.0). Postoperative complications occurred in 44 patients (30.8%) assigned to the low-cost mesh and in 44 patients (29.7%) assigned to the commercial mesh (absolute risk difference, 1.0 percentage point; 95% CI, -9.5 to 11.6; P=1.0).

CONCLUSIONS

Rates of hernia recurrence and postoperative complications did not differ significantly between men undergoing hernia repair with low-cost mesh and those undergoing hernia repair with commercial mesh. (Funded by the Swedish Research Council and others; Current Controlled Trials number, ISRCTN20596933.).

摘要

背景

腹股沟疝修补最有效的方法是使用合成补片,但在中低收入国家,这种补片对许多患者来说负担不起。已使用经消毒的蚊子网作为一种成本较低的替代方法,但尚未对此进行严格研究。

方法

我们进行了一项双盲、随机、对照试验,比较了低成本网片和商业网片(均为轻质网片)在乌干达东部治疗成年男性单侧可复性原发性腹股沟疝中的应用。由 4 名合格的外科医生进行手术。主要结局是 1 年时的疝复发和术后并发症。

结果

共有 302 名患者入组研究。术后 2 周和 1 年的随访率分别为 97.3%和 95.6%。1 名患者(0.7%)在使用低成本网片的情况下出现疝复发,而在使用商业网片的情况下无患者出现疝复发(绝对风险差异为 0.7 个百分点;95%置信区间为 -1.2 至 2.6;P=1.0)。在使用低成本网片的 44 名患者(30.8%)和使用商业网片的 44 名患者(29.7%)中发生了术后并发症(绝对风险差异为 1.0 个百分点;95%置信区间为 -9.5 至 11.6;P=1.0)。

结论

在接受疝修补术的男性中,使用低成本网片与使用商业网片的疝复发率和术后并发症发生率无显著差异。(由瑞典研究理事会和其他机构资助;当前的对照试验编号为 ISRCTN20596933。)

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