NIHR Global Surgery Unit, University of Birmingham, Birmingham, UK.
Institute for Applied Health Research, University of Birmingham, Birmingham, UK.
BJS Open. 2024 Sep 3;8(5). doi: 10.1093/bjsopen/zrae116.
There is a lack of consensus on the management of inguinal hernia with limited symptoms. To address this issue a systematic review of existing randomized clinical trials (RCTs) was performed to critically appraise all existing data on asymptomatic hernia management, focusing on generalizability.
A scoping review to identify all RCTs comparing surgical and conservative management of patients with inguinal hernias was undertaken. Medline, Embase, Cochrane and ClinicalTrials.gov databases were searched. Data collected included study characteristics and definitions of population, intervention/comparator, and outcomes; and limitations of each study were also extracted. The quality and generalizability of included RCTs were evaluated using Cochrane's ROB-2 and the PRECIS-2 tool, respectively.
Searches returned 661 papers; 14 full-text papers were assessed and three RCTs were identified. All RCTs included only male patients with a mean age above 55 years. All RCTs included asymptomatic patients and two included those with minimal symptoms. Different definitions for 'minimally symptomatic' were used in RCTs and none provided details of what was meant by conservative treatment. Follow-up periods varied between studies (1, 2, 3 years). All RCTs had an overall high risk of bias. According to PRECIS-2, two RCTs were classified as pragmatic, and one was equally pragmatic and explanatory.
This systematic review highlights a high risk of bias but a good generalizability of the findings from the RCTs conducted on minimally symptomatic inguinal hernia patients. To improve the guidelines for the management of this group of patients, more generalizable data are needed.
对于症状有限的腹股沟疝管理,目前缺乏共识。为了解决这个问题,我们对现有的随机对照临床试验(RCT)进行了系统评价,以批判性地评估所有关于无症状疝管理的现有数据,重点关注其普遍性。
我们进行了一项范围界定审查,以确定所有比较手术和保守治疗腹股沟疝患者的 RCT。检索了 Medline、Embase、Cochrane 和 ClinicalTrials.gov 数据库。收集的数据包括研究特征和人群、干预/对照和结局的定义;还提取了每项研究的局限性。使用 Cochrane 的 ROB-2 和 PRECIS-2 工具分别评估纳入 RCT 的质量和普遍性。
搜索返回了 661 篇论文;评估了 14 篇全文论文,确定了 3 项 RCT。所有 RCT 均仅纳入了年龄在 55 岁以上的男性患者。所有 RCT 均纳入了无症状患者,其中 2 项 RCT 纳入了症状轻微的患者。RCT 中使用了不同的“轻微症状”定义,且没有一项 RCT 详细说明保守治疗的含义。研究之间的随访时间不同(1、2、3 年)。所有 RCT 的总体偏倚风险均较高。根据 PRECIS-2,两项 RCT 被归类为实用型,一项则兼具实用性和解释性。
本系统评价强调了 RCT 中存在高偏倚风险,但发现结果具有良好的普遍性。为了改善对这群患者的管理指南,需要更具普遍性的数据。