Physical Therapy for Ventral Hernia Repair

(ABVENTURE-P Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Physical Therapy for Ventral Hernia Repair is an effective treatment?

The available research shows that physical therapy is effective in improving recovery after surgeries similar to ventral hernia repair. For example, a study on lumbar disc surgery found that patients who underwent active physiotherapy experienced significant improvements in pain and functionality. They reported less pain and better overall improvement compared to those who did not receive this treatment. Although this study focused on a different type of surgery, it suggests that physical therapy can be beneficial in post-surgical recovery, which could be applicable to ventral hernia repair as well. ^{1 2 3 4 5}

What safety data exists for physical therapy after ventral hernia repair?

The safety data for physical therapy, which may be relevant to post-ventral hernia repair, includes studies on early physical therapy in intensive care units, direct access to physical therapy in university health centers, and safe patient handling in rehabilitation settings. These studies suggest that while physical therapy can be safe, there are potential risks such as physiological abnormalities or adverse events, especially in intensive care settings. Safe patient handling technology is recommended to reduce risks for caregivers. Overall, the data indicates that with proper precautions, physical therapy can be safely administered. ^{6 7 8 9 10}

Is Supervised Physical Therapy a promising treatment for ventral hernia repair?

Yes, Supervised Physical Therapy is a promising treatment for ventral hernia repair. It aims to improve stability and function, potentially reducing pain and disability after surgery. The ABVENTURE-P trial is testing its effectiveness and safety, and early findings suggest it could enhance recovery and quality of life. ^{1 5 11 12 13}

Research Team

Eligibility Criteria

This trial is for adults over 18 with a ventral hernia that's at least 2cm wide, who can move around on their own and are scheduled for elective hernia repair surgery. It's not for those using walkers or canes, already in physical therapy, or with movement/balance disorders.

Inclusion Criteria

I have been diagnosed with a ventral hernia.

My hernia is wider than 2cm.

I am scheduled for surgery to repair a hernia in my abdomen.

Exclusion Criteria

I have been diagnosed with a movement or balance disorder.

I use a walker or cane to help me walk.

I am not currently in, nor planning to start, physical therapy or similar medical exercise programs.

Treatment Details

Interventions

• Post-operative Precautions (Other)
• Supervised Physical Therapy (Behavioural Intervention)

Trial Overview The study is testing if supervised physical therapy helps people recover better after they've had surgery to fix a ventral hernia. Participants will follow post-operative precautions alongside the therapy.

Participant Groups

Group I: Supervised Physical Therapy Experimental Treatment 1 Intervention

Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program.

Group II: Standard Post-operative Instructions Active Control 1 Intervention

Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.

Supervised Physical Therapy is already approved in Canada for the following indications:

Approved in Canada as Physical Therapy for:

• Musculoskeletal injuries
• Neurological conditions
• Post-operative rehabilitation
• Chronic pain management

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

A study involving 1,544 hernia patients revealed that while 52% of surveyed surgeons use physical therapy (PT) for hernia care, many still report it as 'occasional' or 'rarely', indicating a need for broader adoption despite recognizing its benefits.

Surgeons identified barriers to implementing PT, such as lack of education and evidence of clinical benefits, suggesting that addressing these gaps through education and further research could enhance recovery protocols for hernia repair patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and barriers to adopting physical therapy and rehabilitation as standard of care in hernia disease: a prospective national survey of providers and preliminary data. Renshaw, S., Peterson, R., Lewis, R., et al.[2022]

In a 10-year study involving 12,976 patients at a university health center, direct access to physical therapy (PT) showed no reported serious medical issues or adverse events, indicating a high level of safety for patients.

The study concluded that patients receiving care through direct access to PT are at minimal to no risk for negligent care, suggesting that this practice can be safely implemented in similar healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Access to Physical Therapy Services Is Safe in a University Student Health Center Setting. Mintken, PE., Pascoe, SC., Barsch, AK., et al.[2018]

In a clinical trial involving 18 women recovering from liposuction and lipoabdominoplasty, the combination of manual lymphatic drainage and therapeutic ultrasound significantly reduced pain, swelling, and tissue fibrosis during the post-operative period.

The study demonstrated that this treatment approach effectively enhances recovery outcomes, indicating its potential as a standard post-operative care practice for patients undergoing these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage and therapeutic ultrasound in liposuction and lipoabdominoplasty post-operative period. Masson, IF., de Oliveira, BD., Machado, AF., et al.[2021]

A survey of 159 burn rehabilitation professionals revealed that 97% follow their own treatment plans, indicating a lack of standardized protocols in physical rehabilitation across burn centers.

Common practices among therapists include splinting to prevent contractures and treating complications like exposed tendons, highlighting the need for collaborative studies to evaluate and improve treatment interventions and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Select practices in management and rehabilitation of burns: a survey report. Holavanahalli, RK., Helm, PA., Parry, IS., et al.[2018]

References

1. France pubmed.ncbi.nlm.nih.gov

Acceptability and barriers to adopting physical therapy and rehabilitation as standard of care in hernia disease: a prospective national survey of providers and preliminary data. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Preparing for thoraco-abdominal surgery: What's in it for the physiotherapist?] [2022]

3. England pubmed.ncbi.nlm.nih.gov

Erratum. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Active Physiotherapy Rehabilitation on Pain and Global and Functional Improvement 1-2 Months after Lumbar Disk Surgery: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The role of the physical therapist before and after lumbar spine surgery. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Safety profile and feasibility of early physical therapy and mobility for critically ill patients in the medical intensive care unit: Beginning experiences in Korea. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Direct Access to Physical Therapy Services Is Safe in a University Student Health Center Setting. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safe patient handling for rehabilitation professionals. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Influence of Physical Therapists' Kinesiophobic Beliefs on Lifting Capacity in Healthy Adults. [2015]

10. Brazil pubmed.ncbi.nlm.nih.gov

Physiological abnormalities and adverse events during physical therapy in the intensive care unit after cardiac surgery: A prospective observational study. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage and therapeutic ultrasound in liposuction and lipoabdominoplasty post-operative period. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Select practices in management and rehabilitation of burns: a survey report. [2018]