完全腹膜外腹股沟疝修补术与李金斯坦修补术（LEVEL 试验）的比较：一项随机对照试验。

Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial.

机构信息

Department of Surgery, Erasmus MC, Rotterdam, The Netherlands.

出版信息

Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.

DOI:10.1097/SLA.0b013e3181d96c32

PMID:20395851

Abstract

BACKGROUND

This randomized controlled trial was designed to compare the most common technique for open mesh repair (Lichtenstein) with the currently preferred minimally invasive technique (total extra peritoneal, TEP) for the surgical correction of inguinal hernia.

METHODS

A total of 660 patients were randomized to Lichtenstein or TEP procedure. Primary outcomes were postoperative pain, length of hospital stay, period until complete recovery, and quality of life (QOL). Recurrences, operating time, complications, chronic pain, and costs were secondary endpoints. This study was registered at www.clinicaltrials.gov and carries the ID: NCT00788554.

RESULTS

About 336 patients were randomized to TEP, and 324 to Lichtenstein repair. TEP was associated with less postoperative pain until 6 weeks postoperatively (P=0.01). Chronic pain was comparable (25% vs. 29%). Less impairment of inguinal sensibility was seen after TEP (7% vs. 30%, P=0.01). Mean operating time for a unilateral hernia with TEP was longer (54 vs. 49 minutes, P=0.03) but comparable for bilateral hernias. Incidence of adverse events during surgery was higher with TEP (5.8% vs. 1.6%, P<0.004), but postoperative complications (33% vs. 33%), hospital stay and QOL were similar. After TEP, patients had a faster recovery of daily activities (ADL) and less absence from work (P=0.01). After a mean follow-up of 49 months, recurrences (3.8% vs. 3.0%, P=0.64) and total costs (euro3.096 vs. euro3.198) were similar.

CONCLUSION

TEP procedure was associated with more adverse events during surgery but less postoperative pain, faster recovery of daily activities, quicker return to work, and less impairment of sensibility after 1 year. Recurrence rates and chronic pain were comparable. TEP is recommended in experienced hands.

摘要

背景

本随机对照试验旨在比较开放式网片修补术（Lichtenstein 法）与目前首选的微创技术（完全腹膜外，TEP）治疗腹股沟疝的疗效。

方法

共 660 例患者随机分为 Lichtenstein 组或 TEP 组。主要结局为术后疼痛、住院时间、完全恢复时间和生活质量（QOL）。复发、手术时间、并发症、慢性疼痛和成本为次要终点。本研究在 www.clinicaltrials.gov 上注册，编号为 NCT00788554。

结果

约 336 例患者被随机分配至 TEP 组，324 例患者被随机分配至 Lichtenstein 修补组。TEP 组术后疼痛持续时间更短（P=0.01），直至术后 6 周。慢性疼痛无差异（25% vs. 29%）。TEP 后腹股沟感觉受损较轻（7% vs. 30%，P=0.01）。单侧疝 TEP 手术的平均手术时间较长（54 分钟 vs. 49 分钟，P=0.03），但双侧疝无差异。TEP 术中不良事件发生率较高（5.8% vs. 1.6%，P<0.004），但术后并发症（33% vs. 33%）、住院时间和 QOL 相似。TEP 后，患者日常生活活动（ADL）恢复更快，旷工时间更少（P=0.01）。平均随访 49 个月后，复发率（3.8% vs. 3.0%，P=0.64）和总费用（欧元 3096 欧元 vs. 3198 欧元）相似。