Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)

The Ohio State University

Status: Active, not recruiting

Conditions: Herniorrhaphy; Hernia; Postoperative Period; Ventral Hernia; Physical Therapy Modalities; Abdominal Wall

Treatments: Other: Post-operative Precautions; Other: Supervised Physical Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05142618

2021H0336

R01DK131207 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Ages 18+
• Diagnosis of ventral hernia
• Scheduled for elective ventral hernia repair
• Independent functional status
• Transverse hernia width of 2cm or greater

Exclusion Criteria

• Previously diagnosed movement or balance disorder
• Use of ambulatory assistive device (walker or cane)
• Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Standard Post-operative Instructions

Active Comparator group

Description:

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

Treatment:

Other: Post-operative Precautions

Supervised Physical Therapy

Experimental group

Description:

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.

Treatment:

Other: Supervised Physical Therapy