腹股沟疝修补术后的疼痛与生活质量:一项比较轻质补片与重质补片的多中心随机对照试验(Supermesh研究)

Pain and quality of life after inguinal hernia surgery: a multicenter randomized controlled trial comparing lightweight vs heavyweight mesh (Supermesh Study).

作者信息

Bona Stefano, Rosati Riccardo, Opocher Enrico, Fiore Barbara, Montorsi Marco

机构信息

UO di Chirurgia Generale e Digestiva, Humanitas Research Hospital and University, Via Manzoni 56, 20089, Rozzano (Milan), Italy.

UO di Chirurgia Gastroenterologica, Ospedale San Raffaele, 20132, Milan, Italy.

出版信息

Updates Surg. 2018 Mar;70(1):77-83. doi: 10.1007/s13304-017-0483-3. Epub 2017 Aug 8.

Abstract

Mesh repair has significantly reduced recurrence rate after groin hernia surgery. Recently, attention has shifted to issues such as chronic pain and discomfort, leading to development of lightweight and partially re-absorbable meshes. The aim of the study was to evaluate the effect of lightweight mesh vs heavyweight mesh on post-operative pain, discomfort and quality of life in short and medium term after inguinal hernia surgery. Eight hundred and eight patients with primary inguinal hernia were allocated to anterior repair (Lichtenstein technique) using a lightweight mesh (Ultrapro) or a heavyweight mesh (Prolene). Primary outcomes were incidence of chronic pain and discomfort at 6-month follow-up. Secondary endpoints were quality of life (QoL), pain and complication at 1 week, 1 and 6 months. At 6 months, 25% of patients reported pain of some intensity; severe pain was reported by 1% of patients in both groups. A statistically significant difference in favour of lightweight mesh was found at multivariable analysis for pain (1 week and 6 months after surgery: p = 0.02 and p = 0.04, respectively) and QoL at 1 month and 6 months (p = 0.05 and p = 0.02, respectively). There was no difference in complication rate and no hernia recurrences were detected. The use of lightweight mesh in anterior Lichtenstein inguinal hernia repair significantly reduced the incidence of pain and favourably affected the perceived quality of life at 6 months after surgery compared to heavyweight mesh.

摘要

补片修补术已显著降低腹股沟疝手术后的复发率。最近,关注点已转向慢性疼痛和不适等问题,从而推动了轻质和部分可吸收补片的研发。本研究的目的是评估轻质补片与重质补片对腹股沟疝手术后短期和中期的术后疼痛、不适及生活质量的影响。808例原发性腹股沟疝患者被分配接受使用轻质补片(Ultrapro)或重质补片(普理灵)的前路修补术(Lichtenstein技术)。主要结局是6个月随访时慢性疼痛和不适的发生率。次要终点是1周、1个月和6个月时的生活质量(QoL)、疼痛及并发症。6个月时,25%的患者报告有某种程度的疼痛;两组均有1%的患者报告有重度疼痛。在多变量分析中,发现轻质补片在疼痛方面(分别为术后1周和6个月:p = 0.02和p = 0.04)以及1个月和6个月时的生活质量方面(分别为p = 0.05和p = 0.02)有统计学显著差异,支持轻质补片。并发症发生率无差异且未检测到疝复发。与重质补片相比,在Lichtenstein前路腹股沟疝修补术中使用轻质补片可显著降低疼痛发生率,并在术后6个月对感知的生活质量产生有利影响。

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