比较聚丙烯与聚乙交酯丙交酯和聚丙烯复合补片用于腹股沟疝修补术的随机临床试验。

Randomized clinical trial comparing a polypropylene with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty.

作者信息

śmietański M

机构信息

Department of General and Endocrine Surgery and Transplantation, Medical University of Gdańsk, 7 Debinki Street, 80-211 Gdańsk, Poland.

出版信息

Br J Surg. 2008 Dec;95(12):1462-8. doi: 10.1002/bjs.6383.

DOI:10.1002/bjs.6383

PMID:18991255

Abstract

BACKGROUND

: The aim was to assess whether a partially absorbable monofilament mesh could influence postoperative pain and time to return to normal activity after Lichtenstein hernioplasty.

METHODS

: The study randomized patients undergoing inguinal hernia repair in 15 centres into two groups according to mesh type: lightweight (poliglecaprone-polypropylene composite) and heavyweight (polypropylene). A modified suture technique was used in the lightweight group. Follow-up on day 7 and at 3, 6 and 12 months evaluated the incidence of early and late complications, recurrence rate, quality of life, postoperative pain and return to physical activity.

RESULTS

: A total of 600 patients were randomized and, after monitoring visits (leading to the exclusion of seven hospitals), 392 qualified for assessment. At 12 months, the recurrence rate did not differ (1.9 versus 0.6 per cent; P = 0.493). The lightweight group reported less pain on day 7 (55.2 versus 36.2 per cent; P < 0.001) and at 3 months (17.1 versus 9.8 per cent; P = 0.033) but pain was similar for both groups at 1 year. General health and physical activity according to Short Form 36 scores increased in both groups.

CONCLUSION

: Use of partially absorbable mesh reduced postoperative pain in the short term. No difference in pain or recurrence rates were observed at 12 months.

REGISTRATION NUMBER

CCT-NAPN-17412 (http://www.controlled-trials.com) Published by John Wiley & Sons, Ltd.

摘要

背景

目的是评估部分可吸收单丝补片是否会影响李金斯坦疝修补术后的疼痛及恢复正常活动的时间。

方法

该研究将15个中心接受腹股沟疝修补术的患者根据补片类型随机分为两组：轻质（聚乙交酯-聚丙烯复合材料）和重质（聚丙烯）。轻质组采用改良缝合技术。在第7天以及3、6和12个月进行随访，评估早期和晚期并发症的发生率、复发率、生活质量、术后疼痛及恢复体力活动情况。

结果

共有600例患者被随机分组，在监测访视后（导致7家医院被排除），392例符合评估条件。在12个月时，复发率无差异（1.9%对0.6%；P = 0.493）。轻质组在第7天（55.2%对36.2%；P < 0.001）和3个月时（17.1%对9.8%；P = 0.033）报告的疼痛较轻，但两组在1年时疼痛相似。根据简短健康调查问卷36项评分，两组的总体健康和体力活动均有所改善。