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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether supervised physical therapy can enhance recovery after surgery for a ventral hernia, a type of bulge in the abdominal area. Some participants will follow standard post-surgery instructions, while others will attend scheduled supervised physical therapy sessions. Individuals with a ventral hernia at least 2cm wide, who are scheduled for elective repair surgery, may be suitable candidates, particularly if they manage daily tasks independently and do not use a walker or cane. As an unphased trial, this study provides participants the chance to contribute to valuable research that could improve recovery strategies for future patients.

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 prior data suggests that this physical therapy is safe for ventral hernia repair?

Research has shown that supervised physical therapy, often used after ventral hernia repair, is generally safe for patients. One study found that about 87% of patients with a ventral hernia participated in some form of rehabilitation exercises, indicating that most handle this treatment well. No reports have linked serious side effects directly to the physical therapy itself.

Supervised physical therapy involves visiting a therapist who guides exercises to aid recovery after surgery, improving strength and healing. Current studies focus on the effectiveness and safety of these exercises. Given the widespread use and acceptance of physical therapy, it is considered a safe option to support recovery after hernia surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about supervised physical therapy for ventral hernia repair because it offers a structured and hands-on approach to recovery. Unlike the standard of care, which typically involves patients following general post-operative instructions on their own, this method involves regular visits to a physical therapy clinic. This ensures patients receive personalized guidance and support, potentially leading to better outcomes and faster recovery. The emphasis on a standardized, evidence-based rehabilitation program could make significant improvements in post-surgery healing and long-term strength.

What evidence suggests that supervised physical therapy is effective for ventral hernia repair?

Research shows that working with a physical therapist can improve recovery after ventral hernia surgery. In this trial, participants in the physical therapy group will undergo supervised physical therapy treatments. Studies have found that patients in supervised rehabilitation recover faster. A review of several studies found that patients who did physical exercises after surgery experienced a better quality of life. Another study showed that exercising more before surgery led to fewer complications and a lower chance of needing to return to the hospital. This evidence suggests that supervised physical therapy could play a crucial role in recovery after hernia surgery. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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