Review of Complex Recurrent Hernia Repair

• 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.

• Bony Anchoring Reinforcement System (Procedure), also known as Mytec, Fasten, Marlex, Allomax, Alloderm, Strattice, Permacol: 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.

Primary outcomes

• Recurrence Rate [ongoing, average 2.4 years]: Evidence of complex incisional hernia recurrence after treatment with BARS procedure.

Secondary outcomes

• Intra and Post-Operative Complications [ongoing, average 2.4 years]: 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.

Sex: All, ages: 18 Years to 65 Years

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.

Participant flow

Outcome results

• Recurrence Rate (Primary), Number, participants: Candidate for BARS Procedure. 3
• Intra and Post-Operative Complications (Secondary), Number, participants: Candidate for BARS Procedure. 27

Adverse events

Time frame: Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.

Other adverse events by term

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• Sisco M, Dumanian GA. A simple technique to anchor prosthetic mesh to bone. Plast Reconstr Surg. 2005 Dec;116(7):2059-60. doi: 10.1097/01.prs.0000192622.53848.3a. No abstract available. PMID 16327650
• Francis KR, Hoffman LA, Cornell C, Cortese A. The use of Mitek anchors to secure mesh in abdominal wall reconstruction. Plast Reconstr Surg. 1994 Feb;93(2):419-21. doi: 10.1097/00006534-199402000-00034. PMID 8310039

• Andrew I Elkwood, MD, Principal investigator, Institute For Advanced Reconstruction