The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting Abdominal Core Health components in patients recovering from ventral hernia repair. The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral Hernia Repair (VHR).
The main questions it aims to answer are:
* Will tailored PT significantly improve abdominal core strength, biomechanical stability, and functional mobility compared to usual care at 3-months post-surgery? * Will tailored PT lead to higher patient-reported quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up? * Will tailored PT result in decreased healthcare utilization, leading to overall cost savings or neutrality compared to usual care over the first year after VHR?
Researchers will compare the tailored physical therapy group to a usual care group to see if the tailored intervention leads to significant improvements in clinical efficacy, patient outcomes, and cost-effectiveness.
Participants will:
* Be randomly assigned to either the Usual Care Group or the PT Group. * If in the Usual Care Group, receive standard post-operative instructions for 12 weeks, including guidance on binder use, safe lifting, and gradual return to activities. * If in the PT Group, receive foundational post-operative instructions for the first 2 weeks (similar to usual care). Undergo 6 structured and individualized PT sessions over 10 weeks if in the PT Group, with progression based on Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores, including Symptom Modulation, Movement Control, Functional Optimization, or Impairment-Based interventions.
Participants undergo data collection at 2 weeks, 12 weeks, and 1 year post-operation, including imaging, functional mobility tests, pain scales, patient-reported outcomes, physical measurements, and tracking of complications and healthcare utilization. Participate in semi-structured interviews after the 12-week assessment to provide qualitative insights into their experiences and perceived barriers/facilitators.
Participants must be aged 18-75.
Diagnosed clinically or via objective testing by a surgeon with a ventral transverse hernia >4 cm and <10 cm.
Scheduled for elective surgical correction of a non-recurrent, primary or incisional ventral hernia.
Independent functional status.
Individuals currently receiving or who have received PT within the last 30 days.
Individuals currently using an assistive device for ambulation.
Individuals diagnosed with a neurologic disorder will be excluded.
History of or plan for Botox injection or muscle release related to the hernia.
Parallel
PT Group
Other interventionExercise, Manual Therapy, and education
Usual Care
Other interventionEducation
Abdominal Hernia Surgery Quality of Life Questionnaire
a validated patient-reported outcome measure assessing the impact of abdominal wall hernias and their repair on various aspects of quality of life. Scores are typically summed 0-100 with higher scores better.
Bowel Obstruction Occurrence Rate
The proportion or percentage of patients in each group who experience a bowel obstruction within the 1-year follow-up period.
Incidence of Spine/Pelvic Floor Diagnosis
The number of new diagnoses of spine or pelvic floor conditions occurring in each group during the 1-year follow-up period.
Pain Intensity (SF-MPQ-2)
Pain intensity as measured by the Short-Form McGill Pain Questionnaire-2, a multidimensional pain assessment tool providing scores for continuous, intermittent, neuropathic, and affective pain. Scored between 0-220 with higher scores having more pain.
Pain Intensity (NPRS)
Pain intensity as rated by the Numerical Pain Rating Scale, typically a 0-10 scale where 0 represents "no pain" and 10 represents "worst imaginable pain."
Complications & Healthcare Utilization
Tracked via medical record review and structured interviews.
Economic Analysis
Direct costs of PT sessions and healthcare utilization costs (e.g., physician visits, hospital admissions, medications, complication management) will be systematically collected from medical records and billing data. Indirect costs such as lost productivity or time away from work, will be estimated using patient-reported employment status and time off work, valued using average regional wage data.
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