Fragility of randomized clinical trials comparing surgical approaches for inguinal hernia repair: a systematic review.

IF 2.7 2区医学 Q1 SURGERY

Hernia Pub Date : 2026-10-09 DOI:10.1007/s10029-026-03869-3

Maria Clara Morais, Denise Padilha Abs de Almeida, Beatriz Laus Pereira Lima, Leticia Hanna Moura da Silva Gattas Graciolli, Aisulu Jessup, Maria Fernanda Andrade, Raquel Nogueira, Leandro Totti Cavazzola, Flavio Malcher, Diego Laurentino Lima

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引用次数: 0

Abstract

Introduction: Randomized clinical trials (RCTs) remain the reference standard for estimating causal effects of surgical interventions when appropriately designed and conducted. However, P values alone do not describe how sensitive a dichotomous statistical-significance classification is to small changes in outcome counts. The Fragility Index (FI) and Reverse Fragility Index (RFI) are post hoc descriptive metrics that quantify the number of outcome-status changes required to alter statistical significance. This study aimed to evaluate FI/RFI for inguinal hernia repair (IHR) RCT findings, assess individual complication endpoints, and examine associations with sample size and conflict-of-interest reporting.

Methods: Embase, PubMed, LILACS, and ClinicalTrials.gov were searched through June 2025 for RCTs comparing open, laparoscopic, or robotic inguinal hernia repair with dichotomous primary outcomes. FI, RFI, and sample-size-adjusted quotients were calculated from reconstructed 2 × 2 tables using two-sided Fisher exact tests. Individual complications and associations with trial characteristics were analyzed.

Results: Forty-two RCTs comprising 14,505 patients and 44 primary comparisons were included; all eligible comparisons evaluated laparoscopic versus open repair. Twelve comparisons were significant, with a median FI of 4 (IQR, 3-5.25); 4 (33.3%) had an FI of 3 or less. Among 31 nonsignificant comparisons, the median RFI was 5 (IQR, 3.5-6.5). All 4 significant individual-complication results had an FI of 3 or less (median, 1). Significance classification differed between reported and recalculated P values in 4 of 78 extracted comparisons. FI was not significantly correlated with sample size.

Conclusions: Randomized trials remain central to comparative evidence in inguinal hernia repair. FI and RFI provide complementary post hoc context regarding how many outcome-status changes would alter a dichotomous significance classification and should be interpreted alongside prespecified trial design, effect estimates, confidence intervals, P values, sample size, missing data, and clinical relevance.

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比较腹股沟疝修补手术入路的随机临床试验的脆弱性：一项系统综述。

导论：随机临床试验（rct）仍然是评估手术干预因果效应的参考标准，如果设计和实施得当。然而，P值本身并不能描述二分类统计显著性分类对结果计数的微小变化有多敏感。脆弱性指数（FI）和反向脆弱性指数（RFI）是事后描述性指标，用于量化改变统计显著性所需的结果状态变化的数量。本研究旨在评估FI/RFI对腹股沟疝修补术（IHR）的RCT结果，评估个体并发症终点，并检查样本量和利益冲突报告的相关性。方法：检索Embase、PubMed、LILACS和ClinicalTrials.gov截至2025年6月的随机对照试验，比较开放式、腹腔镜或机器人腹股沟疝修补术的两种主要结果。采用双侧Fisher精确检验，从重构的2 × 2表中计算FI、RFI和样本大小调整商。分析个体并发症及其与试验特征的关系。结果：纳入42项随机对照试验，包括14505例患者和44项主要比较；所有符合条件的比较评估了腹腔镜与开放式修复。12个比较具有显著性，中位FI为4 (IQR, 3-5.25)；4例（33.3%）患者FI小于等于3。在31个无显著性比较中，RFI中位数为5 （IQR, 3.5-6.5）。所有4个显著的个体并发症结果的FI均小于或等于3（中位数为1）。在78个提取的比较中，有4个在报告的P值和重新计算的P值之间存在显著性分类差异。FI与样本量无显著相关。结论：随机试验仍然是腹股沟疝修补术比较证据的核心。FI和RFI提供了关于多少结果状态变化会改变二分显著性分类的补充事后背景，并应与预先指定的试验设计、效果估计、置信区间、P值、样本量、缺失数据和临床相关性一起解释。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hernia SURGERY-

CiteScore

4.90

自引率

26.10%

发文量

171

审稿时长

4-8 weeks

期刊介绍： Hernia was founded in 1997 by Jean P. Chevrel with the purpose of promoting clinical studies and basic research as they apply to groin hernias and the abdominal wall . Since that time, a true revolution in the field of hernia studies has transformed the field from a ”simple” disease to one that is very specialized. While the majority of surgeries for primary inguinal and abdominal wall hernia are performed in hospitals worldwide, complex situations such as multi recurrences, complications, abdominal wall reconstructions and others are being studied and treated in specialist centers. As a result, major institutions and societies are creating specific parameters and criteria to better address the complexities of hernia surgery. Hernia is a journal written by surgeons who have made abdominal wall surgery their specific field of interest, but we will consider publishing content from any surgeon who wishes to improve the science of this field. The Journal aims to ensure that hernia surgery is safer and easier for surgeons as well as patients, and provides a forum to all surgeons in the exchange of new ideas, results, and important research that is the basis of professional activity.