Review of Complex Recurrent Hernia Repair (BARS)

Institute For Advanced Reconstruction

Status: Unknown

Conditions: Recurrent Hernia

Treatments: Procedure: Bony Anchoring Reinforcement System

Study type: Observational

Funder types: Other

Identifiers

NCT01644695

BARS

Details and patient eligibility

About

Abdominal wall incisional hernia is a common finding in patients who have undergone previous intra-abdominal surgeries. Common methods of abdominal fascial closure include primary closure, mesh inlay versus onlay, with or without component separation. All these methods have been shown to have recurrence rates for hernia between 3%-60% in the literature. The study describes the investigators innovative and preferred method for reconstruction of the abdominal wall as BARS (bony anchoring reinforcement system). This method manages the abdominal fascial integrity to reduce the recurrence of incisional hernia while providing an aesthetically superior abdominal wall contour.

Full description

• Overview of Research

• 100 anticipated subjects
• Data collection methods- Patients will be evaluated with serial history and physical exams, as well as EMG evaluations. Patients will be asked to report their degree of function and satisfaction.
• Data analysis methods -Data that we will collect from patients will serve as anecdotal evidence to support the research theory.
• We will collect data from patients from testings conducted at the hospital and private office. We will be conducting pre-testing, post-testing, compare results, and surveys.
• The anticipated significance of this research study is that this procedure may greatly improve the quality of life of these severely debilitated patients, reduce the morbidity and mortality rates, and reduce the health care cost burden of chronic care and recurrent hospitalizations.
• The BARS technique for incisional hernia reconstruction provides excellent reinforcement with improved contour, decreased recurrence rates and decreased morbidity for the abdominal wall.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients with recurrent abdominal wall incisional hernias
2. Age > 18
3. No medical contraindications to immunosuppressive therapy (in cases utilizing allograft)
4. Ability and motivation to follow up appropriately
5. Ability and motivation to adhere to rehabilitation regimen
6. Stable sequelae of initial CNS insult

Exclusion Criteria: Minors

1. Pregnancy
2. Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and interfere with follow-up.
3. Patient unable to tolerate surgery, rehabilitation, or immunosuppressive therapy.

Trial design

85 participants in 1 patient group

Candidate for BARS procedure.

Description:

The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.

Treatment:

Procedure: Bony Anchoring Reinforcement System