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随机临床试验比较了腹腔镜疝修补术中使用钛涂层轻质网片和中重量复合材料网片的效果。

Randomized clinical trial of laparoscopic hernia repair comparing titanium-coated lightweight mesh and medium-weight composite mesh.

机构信息

Abdominal Wall Unit, Department of General Surgery, J. M. Morales Meseguer University Hospital, Murcia, Spain.

出版信息

Surg Endosc. 2013 Jan;27(1):231-9. doi: 10.1007/s00464-012-2425-y. Epub 2012 Jul 7.

DOI:10.1007/s00464-012-2425-y
PMID:22773233
Abstract

BACKGROUND

The use of lightweight meshes in incisional hernia repair could have beneficial effects on quality of life. This study aimed to compare a new titanium-coated lightweight mesh with a standard composite mesh after laparoscopic incisional hernia repair.

METHODS

A randomized controlled single-center clinical trial was designed using the basic principle of one unit, one surgeon, one technique (midline incisional hernia with a laparoscopic approach), and two meshes: a lightweight titanium-coated mesh (group 1) and a medium-weight collagen-polyester composite mesh (group 2) used in 102 patients. The primary end points were pain and recurrence. The secondary end points were morbidity and patient outcomes (analgesic consumption, return to everyday activities).

RESULTS

The postoperative complication rates were similar for the two meshes. Pain was significantly less common in group 1 than in group 2 at 1 month (P = 0.029) but was similar for the two groups at 6 months and 1 year. There was a significant difference between the two groups in the average use of analgesics: 6.1 days in group 1 versus 1.6 days in group 2 (P < 0.001). The lightweight group returned to everyday activities after 6.9 days versus 9.7 days for the composite group (P < 0.001). The rate of recurrence did not differ between the two groups at the 2-year follow-up evaluation.

CONCLUSIONS

The light titanium-covered polypropylene mesh was associated with less postoperative pain in the short term, lower analgesic consumption, and a quicker return to everyday activities than the Parietex composite medium-weight mesh. The recurrence rates at 2 years showed no difference between the two groups.

摘要

背景

在切口疝修复中使用轻质网片可能对生活质量有有益的影响。本研究旨在比较腹腔镜切口疝修补术后一种新型钛涂层轻质网片与标准复合网片的效果。

方法

采用单中心、单医生、单技术(中线切口疝,腹腔镜入路)和两种网片的基本原理设计了一项随机对照单中心临床试验,即轻质钛涂层网片(1 组)和中重量胶原蛋白聚酯复合网片(2 组),共纳入 102 例患者。主要终点是疼痛和复发。次要终点是发病率和患者结局(止痛剂消耗、恢复日常活动)。

结果

两组的术后并发症发生率相似。术后 1 个月时,1 组的疼痛明显少于 2 组(P = 0.029),但 6 个月和 1 年时两组相似。两组间平均止痛剂使用量存在显著差异:1 组 6.1 天,2 组 1.6 天(P < 0.001)。轻质组恢复日常活动的时间为 6.9 天,复合组为 9.7 天(P < 0.001)。两组在 2 年随访评估时的复发率无差异。

结论

与 Parietex 复合中重量网片相比,轻质钛涂层聚丙烯网片在短期时术后疼痛较轻、止痛剂消耗较低、恢复日常活动更快。2 年时的复发率两组无差异。

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Early postoperative and one year results of a randomized controlled trial comparing the impact of extralight titanized polypropylene mesh and traditional heavyweight polypropylene mesh on pain and seroma production in laparoscopic hernia repair (TAPP).在腹腔镜疝修补术(TAPP)中比较超轻钛化聚丙烯网片和传统重聚丙烯网片对疼痛和血清肿产生影响的随机对照试验的早期术后和 1 年结果。
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