Surgery versus conservative management for severe pectus excavatum (RESTORE): protocol for a multicentre, randomised, controlled superiority trial.

ABSTRACT:

Introduction

Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

Methods and analysis

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of random

SUBMITTER: Maier R 

PROVIDER: S-EPMC12742100 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature