Review of Complex Recurrent Hernia Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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• 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.

Official Title
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Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)

Conditions
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Recurrent Hernia

Intervention / Treatment
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* Procedure: Bony Anchoring Reinforcement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent abdominal wall incisional hernias Age > 18 No medical contraindications to immunosuppressive therapy (in cases utilizing allograft) Ability and motivation to follow up appropriately Ability and motivation to adhere to rehabilitation regimen Stable sequelae of initial CNS insult Exclusion Criteria: Minors Pregnancy Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and interfere with follow-up. Patient unable to tolerate surgery, rehabilitation, or immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candidate for BARS procedure.<br>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. | Procedure: Bony Anchoring Reinforcement System<br>* Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to secure the mesh to the rest of the abdominal fascia.<br>* Other names: Permacol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate | Evidence of complex incisional hernia recurrence after treatment with BARS procedure. | ongoing, average 2.4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra and Post-Operative Complications | Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery. | ongoing, average 2.4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent, BARS, Bony Anchoring Reinforcement System, Hernia, Incisional, abdominal wall reconstruction, abdominal wall defect, mesh, component separation