随机对照试验研究方案：腹横筋膜前入路腹膜前补片修补术与经腹股沟腹膜前入路修补术治疗腹股沟前疝的比较。

Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure.

机构信息

Department of Surgery, Radboud University Nijmegen Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Gelderland, The Netherlands.

出版信息

Trials. 2013 Mar 3;14:65. doi: 10.1186/1745-6215-14-65.

DOI:10.1186/1745-6215-14-65

PMID:23452397

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3598762/

Abstract

BACKGROUND

Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair.

METHODS

The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients' perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure.

TRIAL REGISTRATION

Current Controlled Trials: ISRCTN18591339.

摘要

背景

使用无张力网片进行开放式腹股沟疝治疗已降低了疝复发的发生率。目前，Lichtenstein 手术是治疗腹股沟疝的参考技术。慢性疼痛已成为手术治疗后腹股沟疝修复的主要术后并发症，尤其是在 Lichtenstein 手术后。通过经腹股沟腹膜前（TIPP）或全腹膜外（TEP）技术在腹膜前间隙（PPS）中放置软网片的初步经验显示，可降低术后慢性疼痛，这一结果很有前景。为了减少慢性疼痛，对腹股沟疝修补术的手术创新不断发展，出现了经腹膜前开放式直接入路，如 TIPP。在 TIPP 手术的基础上，最近又开发了一种新的腹膜前修补术，即经直肠鞘前腹膜前（TREPP）网片修补术。

方法

ENTREPPMENT 试验是一项多中心随机临床试验。患者将根据 TREPP 网片修补术或 TIPP 程序被随机分配到前入路腹股沟疝修补组。所有符合单侧原发性腹股沟疝手术指征的患者都将被邀请参加试验。主要结局指标是术后慢性疼痛患者的数量。次要结局指标包括严重不良事件（SAEs），包括复发、出血、恢复日常活动（例如工作）、手术时间和住院时间。除了临床试验的健康状况外，还将进行经济评估。为了证明 TREPP 技术的腹股沟疝修补术可将术后慢性疼痛患者的比例从 12%降低至<6%，需要 800 例患者（双侧检验，α=0.05，80%效能）。ENTREPPMENT 试验旨在从患者的角度评估 TREPP 和 TIPP 手术。假设与 TIPP 手术相比，TREPP 技术可使任何形式的术后慢性疼痛患者数量减少 50%。