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腹腔镜经腹腹膜前修补术(TAPP)或李金斯坦修补术后 12 年再次复发和疼痛:一项多中心单盲随机临床试验。

Re-recurrence and pain 12 years after laparoscopic transabdominal preperitoneal (TAPP) or Lichtenstein's repair for a recurrent inguinal hernia: a multi-centre single-blinded randomised clinical trial.

机构信息

GastroUnit, Surgical Division, Hvidovre Hospital, University of Copenhagen,, Hvidovre, Denmark.

Surgical Department, University of Southern Denmark, Kolding Hospital, Kolding, Denmark.

出版信息

Hernia. 2020 Aug;24(4):787-792. doi: 10.1007/s10029-020-02139-0. Epub 2020 Feb 25.

Abstract

BACKGROUND

Long-term clinical outcome after a recurrent inguinal hernia repair may be associated with the type of repair, that is, laparoscopic or open. The results from previous randomised controlled trials are inconclusive regarding the long-term risk of re-recurrence chronic pain. Accordingly, this trial compared laparoscopic transabdominal preperitoneal repair (TAPP) with Lichtenstein's repair. The primary outcome was repair for a re-recurrence. The secondary outcome was chronic pain.

METHODS

Multi-centre single-blinded, randomised trial on TAPP vs Lichtenstein's repair in male patients operated for a recurrent inguinal hernia after a primary open inguinal hernia repair. Follow-up for repair for a re-recurrence was registered in the Danish Hernia Database. Prospective follow-up data were achieved by a structured questionnaire on pain-related functional impairment using the Activities Assessment Scale (AAS-pain).

RESULT

A total of 360 patients were randomised, 297 were mailed the follow-up questionnaire (63 excluded) after median 12 years (range 9-15). A total of 265 patients responded to the questionnaire (response rate 89%). The cumulative rate of repair for re-recurrence after 12 years was 10% (95% confidence interval (CI) 5.3-15.1%) vs 10% (5.6-14.7%) after TAPP or Lichtenstein, respectively (p = 0.764). Moderate/severe AAS-pain was reported by 4% (95% CI 1-8%) vs 7% (95% CI 3-11%) patients after TAPP or Lichtenstein, respectively (p = 0.698) CONCLUSION: Long-term re-recurrence rate and incidence of chronic pain was surprisingly high respectless of surgical approach and neither TAPP nor Lichtenstein's procedure was superior to improve surgical results.

摘要

背景

复发性腹股沟疝修补术后的长期临床结果可能与修补类型有关,即腹腔镜或开放。先前的随机对照试验的结果对于慢性疼痛的复发性风险尚无定论。因此,本试验比较了腹腔镜经腹腹膜前修补术(TAPP)与 Lichtenstein 修补术。主要结局是修复复发性疝。次要结局是慢性疼痛。

方法

多中心单盲随机试验,比较了 TAPP 与 Lichtenstein 修补术治疗初次开放性腹股沟疝修补术后复发性男性腹股沟疝。复发性疝的修复随访在丹麦疝数据库中登记。前瞻性随访数据通过使用活动评估量表(AAS-pain)的疼痛相关功能障碍的结构化问卷获得。

结果

共随机分配了 360 例患者,297 例患者在中位数 12 年(范围 9-15 年)后邮寄了随访问卷(排除 63 例)。共有 265 例患者对问卷做出了回应(应答率为 89%)。12 年后修复复发性疝的累积率分别为 10%(95%置信区间(CI)为 5.3-15.1%)和 10%(95%CI 为 5.6-14.7%),TAPP 或 Lichtenstein 组分别为 10%(95%CI 为 5.3-15.1%)和 10%(95%CI 为 5.6-14.7%)(p=0.764)。TAPP 或 Lichtenstein 组分别有 4%(95%CI 为 1-8%)和 7%(95%CI 为 3-11%)的患者报告有中度/重度 AAS-pain(p=0.698)。

结论

无论采用哪种手术方法,长期复发率和慢性疼痛的发生率都出人意料地高,TAPP 和 Lichtenstein 手术均不能改善手术结果。

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