Physical Therapy for Ventral Hernia Repair

(ABVENTURE-P Trial)

Overseen By Ajit Chaudhari, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Movement disorder, Balance disorder, Assistive device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

138 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial information 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 data supports the effectiveness of this treatment for ventral hernia repair?

Research shows that physical therapy and rehabilitation can significantly improve pain and functionality after surgeries like lumbar disc surgery, suggesting similar benefits might be expected for ventral hernia repair. These therapies help patients recover better by reducing pain and improving movement and daily activities. ^{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 physical therapy generally safe for humans?

Research shows that physical therapy is generally safe for humans, even in settings like intensive care units and university health centers, where it has been studied for safety. While some risks exist, such as physiological abnormalities after cardiac surgery, these are typically monitored and managed to ensure patient safety. ^{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}

How does physical therapy differ from other treatments for ventral hernia repair?

Physical therapy for ventral hernia repair is unique because it focuses on improving the stability and function of the abdominal core, rather than just surgically restoring anatomy. This approach aims to enhance recovery by addressing the functional relationships between the abdominal wall, lower back, diaphragm, and pelvic floor, which are often overlooked in standard surgical care. ^{1 5 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Assessment

Participants undergo ventral hernia repair surgery and complete baseline assessments and surveys

Immediate post-surgery

Treatment

Participants receive either supervised physical therapy twice weekly for 8 weeks or follow standard post-operative instructions

8 weeks

16 visits (in-person) for physical therapy group

Follow-up

Participants are monitored for safety and effectiveness with assessments at 30 days, 10 weeks, 6 months, and 1 year after surgery

1 year

Treatment Details

Interventions

• Post-operative Precautions
• Supervised Physical Therapy

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 United States, European Union, Canada for the following indications:

Approved in United States as Physical Therapy for:

• Muscle weakness
• Limitations in range of motion
• Neuromuscular conditions
• Musculoskeletal conditions
• Post-operative rehabilitation

Approved in European Union as Physiotherapy for:

• Neurological disorders
• Orthopedic conditions
• Cardiopulmonary diseases
• Geriatric conditions
• Pediatric conditions

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

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]

Preoperative physiotherapy, particularly inspiratory muscle training and prehabilitation, can enhance exercise capacity and potentially reduce postoperative complications for patients undergoing thoraco-abdominal surgery, although evidence for traditional techniques like bronchial drainage is limited.

Physiotherapists play a crucial role in assessing patients' risk for postoperative morbidity and should tailor preoperative management strategies based on individual risk levels and the latest scientific evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preparing for thoraco-abdominal surgery: What's in it for the physiotherapist?] Laurent, H., Gravier, FE.[2022]

This erratum corrects the author name in a study that followed up for twelve years on the effects of comprehensive physiotherapy after disc herniation surgery, highlighting the long-term impact of rehabilitation on recovery.

The original study, published in 2015, aimed to assess the effectiveness of physiotherapy in improving outcomes for patients post-surgery, emphasizing the importance of accurate author attribution in scientific literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erratum. [2019]

Active physiotherapeutic rehabilitation significantly reduces subjective pain scores and improves functional status in patients 1-2 months after lumbar disc surgery, with a mean difference of -7.01 in pain scores (p = 0.004).

Patients undergoing rehabilitation showed a higher rate of global improvement compared to those who did not, with an odds ratio of 1.94 (p = 0.0001), indicating that structured rehabilitation can enhance recovery outcomes post-surgery.

NCBI (Pubmed)

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. Afzal, K., Khattak, HG., Sajjad, AG., et al.[2022]

Physical therapists play a crucial role in both preoperative and postoperative care, focusing on biomechanical assessments and patient education before surgery, and promoting early movement and exercise after surgery.

An active rehabilitation program led by physical therapists has shown to be more effective than conservative care, helping to reduce postsurgical complications like scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 99 critically ill patients undergoing mobility physical therapy in an intensive care unit, 5% experienced potential safety events, with the most common being respiratory issues like tachypnea and desaturation.

The use of extracorporeal membrane oxygenation (ECMO) significantly increased the risk of adverse events during therapy, highlighting the need for careful monitoring of these patients during mobility sessions.

NCBI (Pubmed)

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. Lee, H., Ko, YJ., Suh, GY., 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]

Therapeutic patient handling tasks in rehabilitation pose a higher risk of work-related musculoskeletal disorders (MSDs) for caregivers due to prolonged exposure to high mechanical loads on the spine.

The use of modern patient handling technology is endorsed by major health organizations to reduce the risk of MSDs, highlighting its importance in safe patient handling programs in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe patient handling for rehabilitation professionals. Waters, TR., Rockefeller, K.[2019]

A study involving 256 physical therapist students found that the kinesiophobic beliefs of examiners significantly impacted the lifting capacity of participants, with those tested by examiners with high kinesiophobia lifting an average of 14.4 kg less if they also held kinesiophobic beliefs.

The results suggest that physical therapists' beliefs about movement can negatively affect their patients' functional abilities, highlighting the need for therapists to be aware of their own beliefs when treating patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Physical Therapists' Kinesiophobic Beliefs on Lifting Capacity in Healthy Adults. Lakke, SE., Soer, R., Krijnen, WP., et al.[2015]

In a study of 323 cardiac surgery patients in the ICU, 20% of physical therapy interventions led to physiological abnormalities or adverse events, with the highest rates occurring during endotracheal suctioning (44%), walking (40%), and noninvasive ventilation (37%).

Despite the occurrence of these events, only 2% resulted in mild harm and 0.2% in moderate harm, indicating that while risks are present, they are generally low; the presence of comorbidities was the only factor significantly associated with these adverse events.

NCBI (Pubmed)

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. Sousa, MLA., Coimbra, VRM., Takei, MT., et al.[2021]

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]

This study aims to evaluate the feasibility and initial efficacy of a physical therapy intervention designed to improve abdominal core stability and function in patients undergoing ventral hernia repair, addressing the common issue of chronic pain and disability post-surgery.

Participants will be randomized to receive either standard care alone or standard care plus up to 16 sessions of physical therapy, with outcomes measured at multiple timepoints to assess the impact of pre-operative core function on therapy responsiveness.

NCBI (Pubmed)

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. Di Stasi, S., Chaudhari, AMW., Renshaw, S., et al.[2023]

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]