A scoping review of outcome reporting in randomized controlled trials of incisional and non-incisional ventral hernia repair

TL;DR

This study reviews how outcomes are reported in hernia repair trials, finding significant inconsistencies that could affect treatment effectiveness and patient care.

Contribution

The study identifies gaps and inconsistencies in outcome reporting for hernia repair RCTs, advocating for standardized measures.

Findings

Short-term operative complications were the most commonly reported outcome in hernia repair RCTs.

Patient-reported outcomes were used in 66.1% of trials, with 15 different assessment tools identified.

There is significant heterogeneity in how outcomes are assessed and defined across studies.

Abstract

Incisional and non-incisional ventral hernias are common and important causes of symptoms, functional restriction, and complications, with significant potential to impact upon quality of life. The goals of hernia repair are to treat, prevent or improve these. However, outcomes of surgery remain relatively poor with significant gaps within the evidence base, which may be due to inconsistent use of outcome measures. The aim of this study was to appraise outcome reporting in the recent literature of randomized controlled trials (RCTs).

This scoping review aimed to map and categorize the outcome measures reported in RCTs of incisional and non-incisional ventral hernia repair.

All RCTs assessing any intervention related to incisional, primary, or recurrent ventral hernia repair between2015 and 2025 were included.

A literature search was performed of the PubMed, EMBASE (1974 to present), and Cochrane Central Register of Controlled Trials databases in November March 2025.

Data was extracted independently by two reviewers. All outcomes reported by the included studies were identified and recorded.

118 RCTs were included. Their outcomes were mapped into five main broad categories. The commonest outcomes used were short-term operative complications (72.9%), hernia recurrence (59.3%), pain (57.6%), and quality of life (33.9%). Patient-reported outcomes were measured in 78 (66.1%) randomized controlled trials, of which 15 assessment tools were identified; 11 were generic, and 4were hernia-specific. There was considerable heterogeneity in how and when these endpoints were assessed and defined.

This scoping review found considerable differences in outcome reporting in contemporary RCTs of incisional and non-incisional ventral hernia. These have significant implications for translating evidence into practice, and its synthesis, and support the need for a core outcome set in this field. However, we identified areas such as abdominal wall function which are infrequently reported and require consideration.

The online version contains supplementary material available at 10.1007/s10029-025-03553-y.

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