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随机临床试验:组织胶水与可吸收缝线在局部麻醉下 Lichtenstein 疝修补术中用于网片固定的比较。

Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair.

机构信息

Kuopio University Hospital, Kuopio, Finland; Central Hospital of Mikkeli, Mikkeli, Finland.

出版信息

Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.

DOI:10.1002/bjs.7598
PMID:21710480
Abstract

BACKGROUND

Chronic pain may be a long-term problem related to mesh fixation and operative trauma after Lichtenstein hernioplasty. The aim of this study was to compare the feasibility and safety of tissue cyanoacrylate glue versus absorbable sutures for mesh fixation in Lichtenstein hernioplasty.

METHODS

Lichtenstein hernioplasty was performed under local anaesthesia as a day-case operation in one of three hospitals. The patients were randomized to receive either absorbable polyglycolic acid 3/0 sutures (Dexon(®); 151 hernias) or 1 ml butyl-2-cyanoacrylate tissue glue (Glubran(®); 151 hernias) for fixation of lightweight mesh (Optilene(®)). Wound complications, pain, discomfort and recurrence were identified at 1 and 7 days, 1 month and 1 year after surgery.

RESULTS

A total of 302 patients were included in the study. The mean(s.d.) duration of operation was 34(12) min in the glue group and 36(13) min in the suture group (P = 0·113). The need for analgesics was similar during the first 24 h after surgery. Five wound infections (3·4 per cent) were detected in the glue group and two (1·4 per cent) in the suture group (P = 0·448). The recurrence rate at 1 year was 1·4 per cent in each group (P = 1·000). The rates of foreign body sensation, acute and chronic pain were similar in the two groups. Logistic regression analysis showed that the type of mesh fixation did not predict chronic pain 1 year after surgery.

CONCLUSION

Mesh fixation without sutures in Lichtenstein hernioplasty was feasible without compromising postoperative outcome.

REGISTRATION NUMBER

NCT00659542 (http://www.clinicaltrials.gov).

摘要

背景

慢性疼痛可能是与补片固定和 Lichtenstein 疝修补术后手术创伤有关的长期问题。本研究旨在比较组织氰基丙烯酸酯胶与可吸收缝线用于 Lichtenstein 疝修补术中补片固定的可行性和安全性。

方法

在一家医院的局部麻醉下进行 Lichtenstein 疝修补术,作为日间手术。患者被随机分为两组,一组接受可吸收聚乙二醇酸 3/0 缝线(Dexon(®);151 例疝),另一组接受 1 毫升丁基-2-氰基丙烯酸酯组织胶(Glubran(®);151 例疝)用于固定轻质补片(Optilene(®))。术后 1 天、7 天、1 个月和 1 年时,记录伤口并发症、疼痛、不适和复发情况。

结果

共有 302 例患者纳入研究。在胶组中,手术时间的平均值(标准差)为 34(12)分钟,在缝线组中为 36(13)分钟(P = 0·113)。术后 24 小时内需要镇痛药物的情况相似。在胶组中发现 5 例(3·4%)伤口感染,缝线组中发现 2 例(1·4%)(P = 0·448)。两组 1 年复发率均为 1·4%(P = 1·000)。两组异物感、急性和慢性疼痛的发生率相似。Logistic 回归分析表明,术后 1 年慢性疼痛与补片固定方式无关。

结论

在 Lichtenstein 疝修补术中不使用缝线固定补片是可行的,不会影响术后结果。

注册号

NCT00659542(http://www.clinicaltrials.gov)。

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