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在腹腔镜经腹腹膜前疝修补术中使用人纤维蛋白胶(Tissucol)与吻合钉进行补片固定的前瞻性随机研究。

Use of human fibrin glue (Tissucol) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty: a prospective, randomized study.

作者信息

Lovisetto Federico, Zonta Sandro, Rota Emanuela, Mazzilli Massimiliano, Bardone Marco, Bottero Luca, Faillace Giuseppe, Longoni Mauro

机构信息

Dipartimento di Scienze Chirurgiche, Rianimatorie-Riabilitative e dei Trapianti d'Organo, Facoltà di Medicina, University of Pavia, Pavia, Italy.

出版信息

Ann Surg. 2007 Feb;245(2):222-31. doi: 10.1097/01.sla.0000245832.59478.c6.

Abstract

OBJECTIVE

The aim of this study was to compare the morbidity of fixation of prosthetic meshes using Tissucol fibrin glue versus staples in laparoscopic transabdominal preperitoneal (TAPP) repair of inguinal and femoral hernias.

SUMMARY BACKGROUND DATA

In patients undergoing laparoscopic hernia repair, fixation of mesh prostheses with staples may affect inguinocrural nerves causing early postoperative neuralgia and chronic neuralgia.

METHODS

Between June 2003 and February 2005, 197 patients with inguinal or femoral hernia were enrolled in this prospective, randomized study, to assess morbidity following hernia repair with staples (n = 98) or Tissucol (n = 99). The primary outcomes were early postoperative and late neuralgia recorded using a visual analog scale (VAS). The effects of neuralgia on functional status were evaluated using the modified SF-36 questionnaire. Secondary outcomes included complications such as nonspecific pain and recurrence.

RESULTS

Assessments took place at 1, 3, 6, and 12 months, with all patients completing each follow-up visit. Mean VAS scores were significantly lower in the Tissucol group versus the staples group (MANOVA, P < 0.05). Higher scores for the modified SF-36 questionnaire at 1 month were demonstrated in the Tissucol group compared with the staples group (23.2 and 22.6, respectively; P < 0.05). The mean recovery time for normal physical activity was significantly shorter in the Tissucol group compared with the staples group (7.9 vs. 9.1 day, respectively; P < 0.001). One recurrence was seen in the fibrin glue group, which was attributable to a technical error in fixation of the mesh.

CONCLUSIONS

The use of Tissucol provides distinct advantages in laparoscopic treatment of inguinal/femoral hernias compared with conventional TAPP, including a lower incidence of postoperative neuralgia and an earlier resumption of physical and social activities.

摘要

目的

本研究旨在比较在腹腔镜经腹腹膜前(TAPP)腹股沟疝和股疝修补术中,使用纤维蛋白胶(Tissucol)与吻合钉固定人工补片的发病率。

总结背景数据

在接受腹腔镜疝修补术的患者中,用吻合钉固定补片假体可能会影响腹股沟股神经,导致术后早期神经痛和慢性神经痛。

方法

2003年6月至2005年2月,197例腹股沟疝或股疝患者纳入了这项前瞻性随机研究,以评估使用吻合钉(n = 98)或纤维蛋白胶(n = 99)进行疝修补术后的发病率。主要结局指标是使用视觉模拟量表(VAS)记录的术后早期和晚期神经痛。使用改良的SF-36问卷评估神经痛对功能状态的影响。次要结局指标包括非特异性疼痛和复发等并发症。

结果

在1、3、6和12个月时进行评估,所有患者均完成了每次随访。纤维蛋白胶组的平均VAS评分显著低于吻合钉组(多变量方差分析,P < 0.05)。与吻合钉组相比,纤维蛋白胶组在1个月时改良SF-36问卷的得分更高(分别为23.2和22.6;P < 0.05)。与吻合钉组相比,纤维蛋白胶组正常体力活动的平均恢复时间显著缩短(分别为7.9天和9.1天;P < 0.001)。纤维蛋白胶组出现1例复发,这归因于补片固定的技术失误。

结论

与传统的TAPP相比,在腹腔镜腹股沟疝/股疝治疗中使用纤维蛋白胶具有明显优势,包括术后神经痛发生率较低以及身体和社交活动恢复较早。

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