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腹腔镜经腹腹膜前疝修补术后慢性疼痛:轻质和超轻质钛化聚丙烯网的随机比较。

Chronic pain after laparoscopic transabdominal preperitoneal hernia repair: a randomized comparison of light and extralight titanized polypropylene mesh.

机构信息

Department of General, Visceral and Vascular Surgery, Agatharied Academic Teaching Hospital of the Ludwig-Maximilians-University Munich, St. Agathastr. 1, 83734, Hausham/Oberbayern, Germany.

出版信息

World J Surg. 2011 Feb;35(2):302-10. doi: 10.1007/s00268-010-0850-4.

Abstract

BACKGROUND

The aim of this prospective, randomized, single-blinded clinical trial was to compare the incidence of chronic pain after laparoscopic transabdominal preperitoneal hernia repair (TAPP) using a 35-g/m2 titanized polypropylene mesh and a 16-g/m2 titanized polypropylene mesh. The reported incidence of chronic pain in patients who underwent laparoscopic hernia repair is a serious problem. The techniques of dissection, mesh fixation, and the mesh material used have all been identified as being part of the problem. Excellent biocompatibility through a unique combination of a lightweight open porous polypropylene mesh covered with a covalent-bonded titanium layer has been claimed. The aim of this study was to find out whether the titanium surface alone or the difference in material load between the two available meshes influences clinical outcomes.

METHODS

Three hundred eighty patients with 466 inguinal hernias were operated on between 2002 and 2006 with the laparoscopic transabdominal preperitoneal (TAPP) technique. Mesh fixation with staples was carried out routinely. After the dissection was completed just prior to the implantation of the mesh, patients were randomized into two groups. In Group A, 250 (53.6%) inguinal hernias were repaired with a 35-g/m2 titanized polypropylene mesh, and in Group B, 216 (46.4%) inguinal hernias were repaired with a 16-g/m2 titanized polypropylene mesh. The primary outcome was chronic pain 3 years after surgery. The degree of pain was determined using a visual analog scale (VAS) with a range from 0 to 10. The secondary outcome was the rate of recurrence.

RESULTS

The postoperative period of observation was at least 3 years for every patient. In both groups, 90% of the patients could be questioned and examined clinically: in Group A (Light), 5.3% of the patients and in Group B (Extralight), 1.5% of the patients suffered from chronic pain. Chronic pain was significantly more common in Group A than in Group B (p=0.037). There was no difference with respect to the rate of recurrence: for Group A it was 3.1% and for Group B it was 2.6% (p=0.724).

CONCLUSIONS

Chronic pain is not very common in patients who have had their inguinal hernias repaired with titanium-covered polypropylene mesh. Reducing the material load from 35 to 16 g/m2 seems to further improve the biocompatibility of these meshes, thus improving the clinical outcome by reducing chronic pain to a rare event. The role of staples in causing chronic pain following inguinal hernia repair may be overestimated. There was no evidence supporting the notion that the use of the 16-g/m2 titanized meshes is associated with increased recurrence rates.

摘要

背景

本前瞻性、随机、单盲临床试验旨在比较腹腔镜经腹腹膜前疝修补术(TAPP)中使用 35g/m2 钛化聚丙烯网片和 16g/m2 钛化聚丙烯网片后慢性疼痛的发生率。据报道,腹腔镜疝修补术后慢性疼痛的发生率是一个严重的问题。已经确定了手术中分离、网片固定和使用的网片材料等技术是导致慢性疼痛的原因之一。据称,一种独特的组合实现了极好的生物相容性,即由轻量的开放式多孔聚丙烯网片和共价键合的钛层组成。本研究旨在确定是否是钛表面本身或两种可用网片之间的材料负荷差异影响了临床结果。

方法

2002 年至 2006 年间,对 380 例 466 例腹股沟疝患者进行了腹腔镜经腹腹膜前(TAPP)手术。常规采用钉固定网片。在完成分离操作,即将网片植入前,将患者随机分为两组。A 组 250 例(53.6%)腹股沟疝患者使用 35g/m2 钛化聚丙烯网片修复,B 组 216 例(46.4%)腹股沟疝患者使用 16g/m2 钛化聚丙烯网片修复。主要结局是术后 3 年慢性疼痛。疼痛程度采用视觉模拟量表(VAS)评估,范围为 0 至 10。次要结局是复发率。

结果

每位患者的观察期至少为 3 年。两组中,90%的患者可接受询问和临床检查:A 组(Light)中 5.3%的患者和 B 组(Extralight)中 1.5%的患者患有慢性疼痛。与 B 组相比,A 组慢性疼痛更常见(p=0.037)。复发率无差异:A 组为 3.1%,B 组为 2.6%(p=0.724)。

结论

使用钛覆盖聚丙烯网片修复腹股沟疝的患者慢性疼痛并不常见。将材料负荷从 35 克/平方米降低至 16 克/平方米似乎进一步提高了这些网片的生物相容性,从而通过将慢性疼痛减少为罕见事件来改善临床结局。钉固定在腹股沟疝修补术后引起慢性疼痛中的作用可能被高估了。没有证据支持使用 16g/m2 钛化网片会增加复发率的观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dbc0/3017304/bd0a0623dea3/268_2010_850_Fig1_HTML.jpg

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