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腹腔镜腹膜外腹股沟疝修补术中网片固定用氰基丙烯酸酯胶水与可吸收钉的比较:一项随机对照试验

Cyanoacrylate Glue Versus Absorbable Tacks in Mesh Fixation for Laparoscopic Extraperitoneal Inguinal Hernia Repair: A Randomized Controlled Trial.

作者信息

Issa Michael, Tacey Mark, Geraghty Joshua, Das Atandrila, Dhir Arun, Mori Krinal, To Henry

机构信息

Department of Surgery.

Office of Research, Northern Health, Epping.

出版信息

Surg Laparosc Endosc Percutan Tech. 2021 Feb 2;31(3):291-297. doi: 10.1097/SLE.0000000000000915.

Abstract

BACKGROUND

Cyanoacrylate glue (Glubran 2) is a synthetic adhesive mesh fixation material. Its utility is being evaluated in laparoscopic total extraperitoneal (TEP) inguinal hernia repair (IHR). A multicentre randomized controlled trial was performed comparing Glubran 2 to standard of care absorbable tacks, particularly assessing chronic postoperative inguinal pain and its effects.

MATERIALS AND METHODS

Patients undergoing elective TEP IHR at 2 centers from 2017 to 2019 were randomly assigned to Glubran 2 or absorbable tack mesh fixation, and followed for 6 months. All other aspects of surgery and aftercare remained the same. Surgeons documented operative and fixation time, and the placement of fixation on standardized diagrams. Via a questionnaire, aspects of inguinal pain were evaluated before surgery, and at various time-points postoperatively over 6 months. Postoperative clinical factors were also collected.

RESULTS

A total of 106 operative sides were randomized to either glue (51) or tack (55) mesh fixation over a 14-month period. Similar median operative times between tack (83.0 min) and glue fixation (75.0 min) were observed. There were no significant surgical complications or observed hernia recurrences in either group. There was no significant difference in pain scores between the 2 groups at all time-points after analysis through mixed effects modeling. Temporal pain profiles over time were also similar. Totally, 55% of patients in the glue group had returned to work within 2 weeks of surgery. There was no increase in complications or pain scores despite regular lateral fixation of glue in these patients.

CONCLUSION

Adding to known data, we observed no significant difference in postoperative pain, demonstrating that cyanoacrylate glue is a viable and safe alternative fixation method to absorbable tacks in laparoscopic TEP IHR. As secondary outcomes, cyanoacrylate glue permits some patients to return to work early, and we observed regular lateral mesh glue fixation without increased pain or complications.

摘要

背景

氰基丙烯酸酯胶水(Glubran 2)是一种合成粘合剂网状固定材料。目前正在腹腔镜完全腹膜外(TEP)腹股沟疝修补术(IHR)中评估其效用。开展了一项多中心随机对照试验,将Glubran 2与护理标准可吸收钉进行比较,特别评估术后慢性腹股沟疼痛及其影响。

材料与方法

2017年至2019年在2个中心接受择期TEP IHR的患者被随机分配至Glubran 2组或可吸收钉网状固定组,并随访6个月。手术和术后护理的所有其他方面均保持相同。外科医生记录手术和固定时间,以及在标准化图表上的固定位置。通过问卷调查,在手术前以及术后6个月的不同时间点评估腹股沟疼痛的各个方面。还收集了术后临床因素。

结果

在14个月期间,共有106个手术侧被随机分配至胶水(51个)或钉(55个)网状固定组。观察到钉固定组(83.0分钟)和胶水固定组(75.0分钟)之间的中位手术时间相似。两组均未出现明显的手术并发症或观察到疝复发。通过混合效应模型分析后,两组在所有时间点的疼痛评分均无显著差异。随时间变化的疼痛情况也相似。总体而言,胶水组55%的患者在术后2周内恢复工作。尽管这些患者定期进行胶水侧方固定,但并发症或疼痛评分并未增加。

结论

补充已知数据后,我们观察到术后疼痛无显著差异,这表明在腹腔镜TEP IHR中,氰基丙烯酸酯胶水是一种可行且安全的可吸收钉替代固定方法。作为次要结果,氰基丙烯酸酯胶水使一些患者能够早日恢复工作,并且我们观察到定期进行胶水侧方网状固定并未增加疼痛或并发症。

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