一项前瞻性、随机临床试验的一年结果比较了四种网片在腹腔镜腹股沟疝修补术（TAPP）中的应用。

One-year results of a prospective, randomised clinical trial comparing four meshes in laparoscopic inguinal hernia repair (TAPP).

机构信息

Department of General and Visceral Surgery, Hernia Center, EuromedClinic Fürth, Europaallee 1, 90763 Fürth, Germany.

出版信息

Hernia. 2011 Oct;15(5):503-10. doi: 10.1007/s10029-011-0810-4. Epub 2011 Apr 3.

DOI:10.1007/s10029-011-0810-4

PMID:21461904

Abstract

BACKGROUND

A low rate of chronic pain and maximum postoperative comfort are the main goals today in inguinal hernia repair. This four-arm randomised trial compares these parameters after laparoscopic hernia repair (TAPP) with a standard heavyweight mesh (HW), a pure middleweight polypropylene mesh (MW), a lightweight composite polypropylene mesh (LW), or a titanised lightweight mesh (TLW). The primary endpoint of the study was the incidence of chronic pain of any severity at the site of hernia repair at 1 year.

METHODS

A total of 600 patients with a laparoscopic inguinal hernia repair and a defect diameter of 3-5 cm were included in the trial. In all patients, a non-invasive mesh fixation technique was performed using fibrin glue. Patients were assessed for pain, foreign body sensation, and physical activities preoperatively, early postoperatively, at 4 weeks, at 6 months, and at 1 year by questionnaire, and were examined clinically. Postoperatively, seroma formation was measured by ultrasound.

RESULTS

At 1 year after TAPP, frequency of pain did not differ statistically between the four groups (depending on type of activity: between 6-8% with HW mesh, 2-4% with middleweight mesh, and 2-4.7% with both lightweight meshes); average intensity of pain was very low, at between VAS 0.4 ± 3.1 and 1.5 ± 7.8 (MW, LW, TLW) and between 1.9 ± 8.6 and 2.3 ± 9.1 (HW) depending on activity (n.s.). Early postoperatively between 31.3% (LW) and 21.3% (TLW) of the patients needed pain medication (n.s.); at 1 year this percentage had dropped to 0.3% (one HW, one MW). Foreign body sensation did not differ but impairment of physical activities (P = 0.0437) was significantly less in the MW, LW, and TLW group (6-12.7%) compared to HW (15.3%) at 4 weeks; at 1 year this percentage was between 0 and 1.3% (n.s.).

CONCLUSION

Compared to HW mesh, the use of MW, LW, and TLW meshes for laparoscopic hernia repair did not significantly affect rate of chronic pain, but seemed to improve early postoperative convalescence. No difference was found between middleweight pure polypropylene (MW), composite lightweight (LW), or titanised lightweight polypropylene (TLW) meshes.

摘要

背景

慢性疼痛发生率低和术后最大舒适度是当今腹股沟疝修补术的主要目标。这项四臂随机试验比较了腹腔镜疝修补术（TAPP）后使用标准重质网片（HW）、纯中质聚丙烯网片（MW）、轻质复合聚丙烯网片（LW）或钛化轻质网片（TLW）的这些参数。该研究的主要终点是术后 1 年时疝修补部位任何严重程度的慢性疼痛发生率。

方法

本试验共纳入 600 例腹腔镜腹股沟疝修补术患者，疝缺损直径为 3-5cm。所有患者均采用纤维蛋白胶行非侵入性网片固定技术。通过问卷调查，在术前、术后早期、4 周、6 个月和 1 年时评估患者的疼痛、异物感和体力活动情况，并进行临床检查。术后通过超声测量血清肿形成情况。

结果

TAPP 术后 1 年时，四组之间疼痛发生率无统计学差异（取决于活动类型：HW 网片为 6-8%，MW 网片为 2-4%，LW 网片为 2-4.7%）；疼痛平均强度非常低，VAS 评分为 0.4±3.1 至 1.5±7.8（MW、LW、TLW）和 1.9±8.6 至 2.3±9.1（HW），取决于活动（无统计学意义）。术后早期，LW（31.3%）和 TLW（21.3%）的患者需要止痛药（无统计学意义）；术后 1 年时，这一比例已降至 0.3%（HW 网片 1 例，MW 网片 1 例）。异物感无差异，但 MW、LW 和 TLW 组在术后 4 周时体力活动受限（P=0.0437）明显少于 HW 组（15.3%）（6-12.7%）；术后 1 年时，这一比例为 0 至 1.3%（无统计学意义）。