Department of General, Vascular and Thoracic Surgery, University of Naples "Federico II", Via Pansini n°5, Naples, Italy,
Hernia. 2014 Apr;18(2):185-92. doi: 10.1007/s10029-012-1020-4. Epub 2012 Nov 20.
In inguinal hernia repair, many complications are due to mesh fixation technique. Therefore, new types of atraumatic methods of fixation have been proposed. In this article, we present the results of a prospective multicentric parallel randomized controlled trial aiming to compare two mesh fixation techniques: fibrin sealant (QUIXIL(®), Omrix Biopharmaceuticals S.A., Belgium) and Lichtenstein technique.
Adult patients with primary uncomplicated inguinal hernia were randomized in two groups: fibrin sealant group (FSG) and Lichtenstein group (LTG). The two groups underwent a follow-up of 15 months. Operative time is the primary outcome. Intraoperative and postoperative outcomes were analyzed. Moreover, a differential cost analysis was performed. Patients and evaluators (with exception of the surgeon who treated the patient) were blinded.
A total of 102 patients, 50 in FSG and 52 in LTG, were enrolled from January 2009 to June 2010, and two patients were lost to follow-up at the twelfth month. No significant differences in baseline and clinical characteristics were observed in the two groups. Operative time was longer in LTG (median/ interquartile range: 35 min/30-42.5 min vs. 31 min/28-35 min; effect size: 0.65/95% CI 0.50-0.91; p < 0.05). No differences in intraoperative complications were observed. No significant differences were observed in early complication rate (RR = 0.62; p > 0.05). Numbness rate was lower in the FSG at 1 week (RR = 0.43; p < 0.01) and at 1 month (RR = 0.17; p < 0.05). No significant differences were observed after 6 months. Postoperative pain was lower in the FSG at 1 week (0/0-1 vs. 1/0-2; p < 0.05) and at 1 month (0/0-0 vs. 0/0-1; p < 0.05). Pain disappeared in all patients after 6 months. Analgesic assumption rate was lower in the FSG (RR = 0.42; p < 0.05). Twenty per cent of FSG and 9.62% of LTG patients were discharged within 12 h; 78% of FSG and 90.38% of LTG patients were discharged within 24 h. The only one recurrence we observed was in FSG group. About costs, although fibrin sealant needed for one mesh fixation is about 10 times more costly than the needed sutures, the total costs of the two procedures did not change significantly. This was mainly due to reduction in operative time.
The use of fibrin sealant determined a significant reduction in short-term numbness rate and postoperative pain. There was no relevant difference in total costs per patient between the two procedures.
在腹股沟疝修补术中，许多并发症与网片固定技术有关。因此，已经提出了新的无创伤固定方法。本文报告了一项前瞻性多中心平行随机对照试验的结果，旨在比较两种网片固定技术：纤维蛋白胶（QUIXIL（®），以色列奥雷生物制药有限公司）和 Lichtenstein 技术。
成年原发性单纯性腹股沟疝患者随机分为两组：纤维蛋白胶组（FSG）和 Lichtenstein 组（LTG）。两组均随访 15 个月。手术时间是主要结局。分析术中及术后结果。此外，还进行了差异成本分析。患者和评估者（除了治疗患者的外科医生外）均设盲。
2009 年 1 月至 2010 年 6 月期间，共有 102 例患者入组，FSG 组 50 例，LTG 组 52 例，其中 2 例患者在第 12 个月失访。两组患者的基线和临床特征无显著差异。LTG 组的手术时间较长（中位数/四分位距：35 分钟/30-42.5 分钟比 31 分钟/28-35 分钟；效应量：0.65/95%CI 0.50-0.91；p < 0.05）。术中并发症无显著差异。早期并发症发生率无显著差异（RR = 0.62；p > 0.05）。术后 1 周（RR = 0.43；p < 0.01）和 1 个月（RR = 0.17；p < 0.05）时，FSG 组麻木发生率较低。6 个月后无显著差异。术后 1 周（0/0-1 比 1/0-2；p < 0.05）和 1 个月（0/0-0 比 0/0-1；p < 0.05）时，FSG 组术后疼痛较低。6 个月后所有患者疼痛消失。FSG 组镇痛药物使用率较低（RR = 0.42；p < 0.05）。20%的 FSG 组和 9.62%的 LTG 组患者在 12 小时内出院；FSG 组 78%和 LTG 组 90.38%的患者在 24 小时内出院。我们观察到的唯一复发病例发生在 FSG 组。关于成本，虽然纤维蛋白胶固定一个网片的费用约是缝线的 10 倍，但两种手术的总费用没有显著变化。这主要是由于手术时间的缩短。
使用纤维蛋白胶可显著降低短期麻木发生率和术后疼痛。两种手术的总患者成本无显著差异。
