经腹筋膜固定与非固定治疗开放型腹横肌后腹疝修补术：一项随机临床试验。

Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial.

机构信息

Department of Surgery, Cleveland Clinic Center for Abdominal Core Health, Cleveland Clinic Foundation, Cleveland, Ohio.

Department of Statistics, Cleveland Clinic Foundation, Cleveland, Ohio.

出版信息

JAMA Surg. 2023 Aug 1;158(8):789-795. doi: 10.1001/jamasurg.2023.1786.

DOI:10.1001/jamasurg.2023.1786

PMID:37342018

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10285673/

Abstract

IMPORTANCE

Transfascial (TF) mesh fixation in open retromuscular ventral hernia repair (RVHR) has been advocated to reduce hernia recurrence. However, TF sutures may cause increased pain, and, to date, the purported advantages have never been objectively measured.

OBJECTIVE

To determine whether abandonment of TF mesh fixation would result in a noninferior hernia recurrence rate at 1 year compared with TF mesh fixation in open RVHR.

DESIGN, SETTING, AND PARTICIPANTS: In this prospective, registry-based, double-blinded, noninferiority, parallel-group, randomized clinical trial, a total of 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure were enrolled at a single center from November 29, 2019, to September 24, 2021. Follow-up was completed December 18, 2022.

INTERVENTIONS

Eligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions.

MAIN OUTCOME AND MEASURES

The primary outcome was to determine whether no TF suture fixation was noninferior to TF suture fixation for open RVHR with regard to recurrence at 1 year. A 10% noninferior margin was set. The secondary outcomes were postoperative pain and quality of life.

RESULTS

A total of 325 adults (185 women [56.9%]; median age, 59 [IQR, 50-67] years) with similar baseline characteristics were randomized; 269 patients (82.8%) were followed up at 1 year. Median hernia width was similar in the TF fixation and no fixation groups (15.0 [IQR, 12.0-17.0] cm for both). Hernia recurrence rates at 1 year were similar between the groups (TF fixation, 12 of 162 [7.4%]; no fixation, 15 of 163 [9.2%]; P = .70). Recurrence-adjusted risk difference was found to be -0.02 (95% CI, -0.07 to 0.04). There were no differences in immediate postoperative pain or quality of life.

CONCLUSIONS AND RELEVANCE

The absence of TF suture fixation was noninferior to TF suture fixation for open RVHR with synthetic mesh. Transfascial fixation for open RVRH can be safely abandoned in this population.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03938688.

摘要

重要性

在开放式腹横肌后入路修复术（RVHR）中，经筋膜（TF）网片固定已被提倡用于减少疝复发。然而，TF 缝线可能会引起更多的疼痛，而且迄今为止，其所谓的优势从未得到客观衡量。

目的

确定在开放式 RVHR 中放弃 TF 网片固定是否会导致 1 年时疝复发率无差异，而非低于 TF 网片固定。

设计、设置和参与者：这是一项前瞻性、基于注册、双盲、非劣效性、平行组、随机临床试验，共纳入 325 名筋膜闭合的疝缺损宽度为 20cm 或更小的腹侧疝患者，在 2019 年 11 月 29 日至 2021 年 9 月 24 日在一家中心入组。随访于 2022 年 12 月 18 日完成。

干预措施

符合条件的患者被随机分配接受经皮 TF 缝线固定或无网片固定的假切口。

主要结局和测量指标

主要结局是确定在开放式 RVHR 中，无 TF 缝线固定是否不劣于 TF 缝线固定，在 1 年时的复发率。设定了 10%的非劣效性边缘。次要结局是术后疼痛和生活质量。

结果

共纳入 325 名成年人（185 名女性[56.9%]；中位年龄为 59 [IQR，50-67] 岁），两组基线特征相似；269 名患者（82.8%）在 1 年时进行了随访。TF 固定组和无固定组的疝宽度中位数相似（分别为 15.0[IQR，12.0-17.0]cm）。两组 1 年时疝复发率相似（TF 固定组 162 例中有 12 例[7.4%]；无固定组 163 例中有 15 例[9.2%]；P = .70）。复发调整风险差为 0.02（95%CI，-0.07 至 0.04）。两组即刻术后疼痛或生活质量无差异。