Sun Ping, Cheng Xiang, Deng Shichang, Hu Qinggang, Sun Yi, Zheng Qichang
Department of Hepatobiliary Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue., Wuhan, Hubei Province, China, 430022.
Department of Gastrointestinal Surgery, Union Hospital West Campus, Tongji Medical College, Huazhong University of Science and Technology, 58 Shenlong Avenue., Wuhan, Hubei, China, 430056.
Cochrane Database Syst Rev. 2017 Feb 7;2(2):CD010814. doi: 10.1002/14651858.CD010814.pub2.
Chronic pain following mesh-based inguinal hernia repair is frequently reported, and has a significant impact on quality of life. Whether mesh fixation with glue can reduce chronic pain without increasing the recurrence rate is still controversial.
To determine whether tissue adhesives can reduce postoperative complications, especially chronic pain, with no increase in recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair.
We searched the following electronic databases with no language restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL; issue 4, 2016) in the Cochrane Library (searched 11 May 2016), MEDLINE Ovid (1986 to 11 May 2016), Embase Ovid (1986 to 11 May 2016), Science Citation Index (Web of Science) (1986 to 11 May 2016), CBM (Chinese Biomedical Database), CNKI (China National Knowledge Infrastructure), VIP (a full-text database in China), Wanfang databases. We also checked reference lists of identified papers (included studies and relevant reviews).
We included all randomised and quasi-randomised controlled trials comparing glue versus sutures for mesh fixation in Lichtenstein hernia repair. Cluster-RCTs were also eligible.
Two review authors extracted data and assessed the risk of bias independently. Dichotomous outcomes were expressed as odds ratio (OR) with 95% confidence intervals (CI). Continuous outcomes were expressed as mean differences (MD) with 95% CIs.
Twelve trials with a total of 1932 participants were included in this review. The overall postoperative chronic pain in the glue group was reduced by 37% (OR 0.63, 95% CI 0.44 to 0.91; 10 studies, 1418 participants, low-quality evidence) compared with the suture group. However, the results changed when we conducted subgroup analysis with regard to the type of mesh. Subgroup analysis of included studies using lightweight mesh showed the reduction of chronic pain was less profound and insignificant (OR 0.77, 95% CI 0.50 to 1.17). Subgroup analysis of included studies using heavyweight mesh resulted in a significant benefit from the fixation with glue (OR 0.38, 95% CI 0.17 to 0.82).Hernia recurrence was similar between the two groups (OR 1.44, 95% CI 0.63 to 3.28; 12 studies, 1932 participants, low-quality evidence). Fixation with glue was superior to suture regarding duration of the operation (MD -3.13, 95% CI -4.48 to -1.78; 9 studies, 1790 participants, low-quality evidence); haematoma (OR 0.52, 95% CI 0.31 to 0.86; 10 studies, 1384 participants, moderate-quality evidence); and recovery time to daily activities (MD -1.26, 95% CI -1.89 to -0.63; 3 studies, 403 participants, low-quality evidence).We also investigated adverse events. There were no significant differences between the two groups. For superficial wound infection pooled analyses showed OR 1.23, 95% CI 0.37 to 4.11; 7 studies, 763 participants (low-quality evidence); for mesh/deep infection OR 0.67, 95% CI 0.16 to 2.83; 8 studies, 1393 participants (low-quality evidence). Furthermore, we investigated seroma (a postoperative swelling caused by fluid) (OR 0.83, 95% CI 0.51 to 1.33); and persisting numbness (OR 0.81, 95% CI 0.57 to 1.14).Finally, six trials involving 1009 participants reported postoperative length of stay, resulting in non-significant difference between the two groups (MD -0.12, 95% CI: -0.35 to 0.10)Due to the lack of data, it was impossible to draw any distinction between synthetic glue and biological glue.Eight out of 12 trials showed high risk of bias in at least one of the investigated domains. Two studies were quasi-randomised controlled trials and the allocation sequence of one trial was not concealed. Nearly half of the included trials either did not provide adequate information or had high risk of bias regarding blinding processes. The risk of bias for incomplete outcome data of all the included studies varied from low to high risk of bias. Two trials did not report on some important outcomes. One study was funded by the manufacturer producing the fibrin sealant. Therefore, according to the 'Summary of findings' tables, the quality of the evidence (GRADE) for the outcomes is moderate to low.
AUTHORS' CONCLUSIONS: Based on the short-term results, glue may reduce postoperative chronic pain and not simultaneously increase the recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair. Glue may therefore be a sensible alternative to suture for mesh fixation in Lichtenstein repair. Larger trials with longer follow-up and high quality are warranted. The difference between synthetic glue and biological glue should also be assessed in the future.
基于补片的腹股沟疝修补术后慢性疼痛屡见报道,对生活质量有显著影响。补片用胶水固定能否在不增加复发率的情况下减轻慢性疼痛仍存在争议。
与利氏疝修补术中用缝线固定补片相比,确定组织胶水能否减少术后并发症,尤其是慢性疼痛,且不增加复发率。
我们检索了以下无语言限制的电子数据库:Cochrane图书馆中的Cochrane系统评价中心注册库(CENTRAL;2016年第4期)(检索日期为2016年5月11日)、Ovid MEDLINE(1986年至2016年5月11日)、Ovid Embase(1986年至2016年5月11日)、科学引文索引(科学网)(1986年至2016年5月11日)、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库。我们还检查了已识别论文(纳入研究和相关综述)的参考文献列表。
我们纳入了所有比较利氏疝修补术中胶水与缝线固定补片的随机对照试验和半随机对照试验。整群随机对照试验也符合要求。
两名综述作者独立提取数据并评估偏倚风险。二分法结局以比值比(OR)及95%置信区间(CI)表示。连续型结局以均数差(MD)及95%CI表示。
本综述纳入了12项试验,共1932名参与者。与缝线组相比,胶水组术后总体慢性疼痛降低了37%(OR=0.63,95%CI 0.44至0.91;10项研究,1418名参与者,低质量证据)。然而,当我们根据补片类型进行亚组分析时,结果发生了变化。对纳入的使用轻质补片的研究进行亚组分析显示,慢性疼痛的降低幅度较小且无统计学意义(OR=0.77,95%CI 0.50至1.17)。对纳入的使用重磅补片的研究进行亚组分析表明,胶水固定有显著益处(OR=0.38,95%CI 0.17至0.82)。两组间疝复发情况相似(OR=1.44,95%CI 0.63至3.28;12项研究,1932名参与者,低质量证据)。在手术时长方面,胶水固定优于缝线(MD=-3.13,95%CI -4.48至-1.78;9项研究,1790名参与者,低质量证据);在血肿方面(OR=0.52,95%CI 0.31至0.86;10项研究,1384名参与者,中等质量证据);在恢复日常活动时间方面(MD=-1.26,95%CI -1.89至-0.63;3项研究,403名参与者,低质量证据)。我们还调查了不良事件。两组间无显著差异。对于浅表伤口感染,汇总分析显示OR=1.23,95%CI 0.37至4.11;7项研究,763名参与者(低质量证据);对于补片/深部感染,OR=0.67,95%CI 0.16至2.83;8项研究,1393名参与者(低质量证据)。此外,我们调查了血清肿(一种由液体引起的术后肿胀)(OR=0.83,95%CI 0.51至1.33);以及持续性麻木(OR=0.81,95%CI 0.57至1.14)。最后,6项涉及1009名参与者的试验报告了术后住院时间,两组间无显著差异(MD=-0.12,95%CI:-0.35至0.10)。由于缺乏数据,无法区分合成胶水和生物胶水。12项试验中的8项在至少一个调查领域显示出高偏倚风险。两项研究为半随机对照试验,其中一项试验的分配序列未被隐藏。几乎一半的纳入试验要么未提供充分信息,要么在盲法过程方面存在高偏倚风险。所有纳入研究的不完整结局数据的偏倚风险从低到高不等。两项试验未报告一些重要结局。一项研究由生产纤维蛋白密封剂的制造商资助。因此,根据“结果总结”表,结局证据的质量(GRADE)为中等至低等。
基于短期结果,与利氏疝修补术中用缝线固定补片相比,胶水可能会减轻术后慢性疼痛且不同时增加复发率。因此,在利氏修补术中,胶水可能是缝线固定补片的合理替代方法。有必要开展随访时间更长、质量更高的大型试验。未来还应评估合成胶水和生物胶水之间的差异。