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NCT05142618 | Recruiting | Ventral Hernia


Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Sponsor:

Ohio State University

Information provided by (Responsible Party):

Ajit Chaudhary

Brief Summary:

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

Condition or disease

Ventral Hernia

Hernia

Herniorrhaphy

Abdominal Wall

Postoperative Period

Physical Therapy Modalities

Intervention/treatment

Supervised Physical Therapy

Post-operative Precautions

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 94 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : September 30, 2024
Arm Intervention/treatment

Active Comparator: Standard Post-operative Instructions

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

Other: Post-operative Precautions

Experimental: Supervised Physical Therapy

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.

Other: Supervised Physical Therapy

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

  • Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

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    Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

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    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Recruiting

    United States, Ohio

    Ohio State University Wexner Medical Center

    Columbus, Ohio, United States, 43210

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