ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial

Abstract

Hernia disease is one of the most common reasons patients seek surgical treatment, yet nearly 1 in 4 patients seeking ventral hernia repair in the United States suffer from chronic pain, disability, and diminished physical activity. The relationships between the anterior abdominal wall, lower back, diaphragm, and pelvic floor are critical in providing function and quality of life, yet management of hernia disease has been limited to surgical restoration of anatomy without taking into consideration the functional relationships of the abdominal core. Therefore, the primary goal of this study is to evaluate the feasibility of implementing physical therapy targeted to improving stability and function in this population. A secondary goal is to estimate whether pre-operative abdominal core function predicts responsiveness to physical therapy. This study is a registry-based randomized controlled trial (NCT05142618: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)). All participants will be randomized to one of two post-operative treatment arms: standard of care plus up to 16 sessions of physical therapy, or standard of care alone. Primary timepoints include pre-operative (baseline) and ten weeks after surgery, with intermediate or secondary timepoints 30 days, 6 months, and 1 year post-operative. At each timepoint, participants will undergo functional and patient-reported outcome testing. We will also collect data on retention rate and treatment adherence. An intention to treat approach is planned for all analyses, using all participants who were randomized and have available data at the 10-week timepoint. This is a pilot and feasibility trial, hence our goals are to establish safety and initial efficacy of the PT intervention, retention and adherence to both PT and control arms, whether pre-operative abdominal core function predicts responsiveness to PT, and to collect a large enough sample to power a future definitive multi-center randomized controlled trial.