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单中心、单盲、随机研究:开放腹股沟疝修补术中自固定补片与缝合补片的比较

Single-center, single-blinded, randomized study of self-gripping versus sutured mesh in open inguinal hernia repair.

作者信息

Nikkolo Ceith, Vaasna Tiit, Murruste Marko, Seepter Helmut, Suumann Jaanus, Tein Andres, Kirsimägi Ülle, Lepner Urmas

机构信息

Depatment of the General Surgery and Plastic Surgery, Surgery Clinic, Tartu University Hospital, Tartu, Estonia.

Depatment of the General Surgery and Plastic Surgery, Surgery Clinic, Tartu University Hospital, Tartu, Estonia.

出版信息

J Surg Res. 2015 Mar;194(1):77-82. doi: 10.1016/j.jss.2014.09.017. Epub 2014 Sep 18.

DOI:10.1016/j.jss.2014.09.017
PMID:25307886
Abstract

BACKGROUND

The primary aim of the present study was to evaluate whether usage of self-gripping mesh in open inguinal hernia repair, compared with standard Lichtenstein repair with sutured mesh, could result in a decreased rate of chronic pain at 6-mo follow-up. The secondary outcome was to evaluate foreign body feeling and the quality of life after inguinal hernia repair.

METHODS

The patients were randomized into two study groups as follows: the OLP group received Optilene LP mesh and the PPG group received self-gripping Parietex ProGrip mesh. Pain scores were measured on a visual analog scale. Foreign body feeling was registered as a yes or no question. Quality of life was evaluated using the Medical Outcome Study Short-Form 36 questionnaire.

RESULTS

A total of 75 patients in the OLP group and 70 patients in the PPG group were included in the analysis. According to the primary end point, 45.3% and 31.4% of the patients in the OLP group and PPG group experienced pain during different activities at 6-mo follow-up, respectively (P = 0.092). Per secondary end point, 22.7% in the OLP group and 40% in the PPG group reported foreign body feeling at the operation site at 6-mo follow-up (P = 0.031, risk ratio 0.57, 95% confidence interval 0.29-1.07). There were no significant differences in any domain of quality of life according to the Short-Form 36 questionnaire between the two study groups at 6-mo follow-up, except for the social functioning domain (P = 0.035). In the OLP group, the quality of life scores improved significantly after operation in all domains except for general health and mental health. In the PPG group, the quality of life scores improved significantly after operation in the domains of bodily pain, physical functioning, and physical role.

CONCLUSIONS

Self-gripping mesh compared with standard Lichtenstein operation has no advantages in reducing chronic pain 6-mo after surgery. The rate of foreign body feeling was higher in the self-gripping mesh group. Scores of bodily pain, physical functioning, and physical role improved significantly in both study groups after hernia surgery.

摘要

背景

本研究的主要目的是评估在开放腹股沟疝修补术中使用自固定补片与采用缝合补片的标准Lichtenstein修补术相比,在6个月随访时慢性疼痛发生率是否会降低。次要结果是评估腹股沟疝修补术后的异物感和生活质量。

方法

将患者随机分为两个研究组:OLP组接受Optilene LP补片,PPG组接受自固定Parietex ProGrip补片。采用视觉模拟量表测量疼痛评分。异物感记录为是或否的问题。使用医学结局研究简明健康调查36项问卷评估生活质量。

结果

OLP组共75例患者、PPG组共70例患者纳入分析。根据主要终点,OLP组和PPG组分别有45.3%和31.4%的患者在6个月随访时在不同活动期间经历疼痛(P = 0.092)。根据次要终点,OLP组22.7%、PPG组40%的患者在6个月随访时报告手术部位有异物感(P = 0.031,风险比0.57,95%置信区间0.29 - 1.07)。在6个月随访时,根据简明健康调查36项问卷,除社会功能领域外(P = 0.035),两个研究组在生活质量的任何领域均无显著差异。在OLP组,除总体健康和心理健康外,所有领域的生活质量评分术后均显著改善。在PPG组,术后身体疼痛、身体功能和身体角色领域的生活质量评分显著改善。

结论

与标准Lichtenstein手术相比,自固定补片在术后6个月减少慢性疼痛方面无优势。自固定补片组的异物感发生率更高。两个研究组在疝修补术后身体疼痛、身体功能和身体角色评分均显著改善。

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