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一项关于腹腔镜完全腹膜外腹股沟疝修补术(TULP试验)中轻质(Ultrapro)与重质补片(普理灵)对比的随机双盲前瞻性试验的长期结果

Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial).

作者信息

Burgmans Josephina P J, Voorbrood Charlotte E H, Simmermacher Rogier K J, Schouten Nelleke, Smakman Niels, Clevers GeertJan, Davids Paul H P, Verleisdonk EgbertJan M M, Hamaker Marije E, Lange Johan F, van Dalen Thijs

机构信息

*Department of Surgery/Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands †Department of Surgery, UMCU Utrecht, Utrecht, The Netherlands ‡Department of Surgery, Heerlen, The Netherlands §Department of Geriatric Medicine, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands ¶Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

Ann Surg. 2016 May;263(5):862-6. doi: 10.1097/SLA.0000000000001579.

Abstract

OBJECTIVE

The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair.

BACKGROUND

Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates.

METHODS

Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores.

RESULTS

During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4-10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected.

CONCLUSIONS

In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.

摘要

目的

这项随机临床试验的目的是比较用于腹腔镜完全腹膜外(TEP)腹股沟疝修补术的轻质(Ultrapro)网片与重质(普理灵)网片的2年临床疗效。

背景

轻质网片可减轻开放前路腹股沟疝修补术后的疼痛和僵硬。关于腹腔镜修补术是否有类似益处的讨论仍在进行中,但有人担心复发率会更高。

方法

在2010年3月至2012年10月期间,患有原发性、可复性单侧腹股沟疝且接受日间TEP修补术的男性患者符合条件。结果参数包括慢性疼痛、复发、异物感和生活质量评分。

结果

在研究期间,共纳入950例患者。术后1年,轻质网片组相关疼痛(数字评分4 - 10分)的发生率(2.9%)显著高于重质网片组(0.7%)(P = 0.01),2年后这种差异仍然显著(P = 0.03)。重质网片组有4例(0.8%)复发性疝,轻质网片组有13例(2.7%)(P = 0.03)。未检测到异物感或生活质量评分的差异。

结论

在TEP疝手术中,术后2年未观察到轻质网片比重质网片有优势。

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