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腹腔镜穿刺孔伤口使用皮肤粘合剂与经皮缝合的美容效果:一项前瞻性随机对照试验。

Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial.

作者信息

Buchweitz Olaf, Frye Christian, Moeller Claus Peter, Nugent Wolfgang, Krueger Eckart, Nugent Andreas, Biel Peter, Juergens Sven

机构信息

Tagesklinik Altonaer Strasse, Altonaer Str. 57-61, 20357, Hamburg, Germany.

Department of Gynecology and Obstetrics, University Hospital, Münster, Germany.

出版信息

Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.

Abstract

BACKGROUND

In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS).

METHODS

A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It was decided randomly which port site would be closed with SA. The opposite site was closed with TS. Wounds were assessed after 7-12 days and after 3 months. Cosmetic outcome was measured by a visual analogue scale (VAS) completed by the patient, by the Hollander wound evaluation scale (HWES) and by the judgement of blinded investigators.

RESULTS

Seventy-seven subjects were randomized. Complete data from the 3-month follow-up visit were available from 56 patients (72.7 %). The VAS scale ranged from 0 to 100 mm with "0" representing the best possible cosmetic outcome. Median satisfaction was 2 mm in the TS group and 3 mm in the SA group. The mean was high in both groups 4.6 (s = 13.1) versus 3.8 mm (s = 4.6). The outcome was neither clinically nor statistically significant. Cosmetic outcome was assessed by an investigator, and the HWES showed no difference. In regard to complications, no difference was found between SA and TS, either.

CONCLUSIONS

In conclusion this study demonstrated that closure of laparoscopic port-site wounds leads to equivalent outcomes whether SAs or TSs are used. Complications are rare in both methods. Thus, SAs seem to be a valid alternative to sutures in laparoscopic surgery. Registration site: www.clinicaltrials.gov .

REGISTRATION NUMBER

NCT02179723.

摘要

背景

在择期腹腔镜手术中,美容效果变得越来越重要。我们开展了一项研究,以评估腹腔镜手术后3个月的美容效果,并比较皮肤黏合剂(SA)与经皮缝合(TS)的效果。

方法

在德国汉堡的一个研究中心进行了一项随机、对照、前瞻性研究。77例接受腹腔镜手术且有两个下腹部切口部位的患者符合研究要求。随机决定用皮肤黏合剂封闭哪个切口部位。相对的部位用经皮缝合封闭。在术后7 - 12天和3个月后对伤口进行评估。美容效果通过患者完成的视觉模拟量表(VAS)、霍兰德伤口评估量表(HWES)以及盲法研究者的判断来衡量。

结果

77名受试者被随机分组。56例患者(72.7%)有3个月随访的完整数据。VAS量表范围为0至100毫米,“0”代表最佳美容效果。经皮缝合组的中位满意度为2毫米,皮肤黏合剂组为3毫米。两组均值均较高,分别为4.6(标准差 = 13.1)毫米和3.8毫米(标准差 = 4.6)。结果在临床和统计学上均无显著差异。由研究者评估美容效果,HWES显示无差异。在并发症方面,皮肤黏合剂和经皮缝合之间也未发现差异。

结论

总之,本研究表明,无论使用皮肤黏合剂还是经皮缝合,腹腔镜切口部位伤口的闭合效果相当。两种方法的并发症都很少见。因此,在腹腔镜手术中,皮肤黏合剂似乎是缝合的一种有效替代方法。注册网站:www.clinicaltrials.gov

注册号

NCT02179723 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ccd/4887523/cc2540da3e4d/464_2015_4474_Fig1_HTML.jpg

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