Clinical trial NCT01644695: Review of Complex Recurrent Hernia Repair
Official title: Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Hernia
Keywords: BARS
Bony Anchoring Reinforcement System
Hernia
Incisional
Recurrent
abdominal wall reconstruction
abdominal wall defect
mesh
component separation
Lead sponsor: Institute For Advanced Reconstruction
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Over 18 with Hernia. Included men and women, minorities, and non-english speakers.

Brief summary: 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: • 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.

Eligibility 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.

Primary outcomes:
measure: Recurrence Rate
timeFrame: ongoing, average 2.4 years
Secondary outcomes:
measure: Intra and Post-Operative Complications
timeFrame: ongoing, average 2.4 years
Other outcomes:
Locations:
city: Shrewsbury
country: United States
facility: Institute For Advanced Reconstruction
state: New Jersey
Study officials:
affiliation: Institute For Advanced Reconstruction
name: Andrew I Elkwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tong WM, Hope W, Overby DW, Hultman CS. Comparison of outcome after mesh-only repair, laparoscopic component separation, and open component separation. Ann Plast Surg. 2011 May;66(5):551-6. doi: 10.1097/SAP.0b013e31820b3c91.
citation: Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023.
citation: Hawn MT, Snyder CW, Graham LA, Gray SH, Finan KR, Vick CC. Long-term follow-up of technical outcomes for incisional hernia repair. J Am Coll Surg. 2010 May;210(5):648-55, 655-7. doi: 10.1016/j.jamcollsurg.2009.12.038.
citation: Bisgaard T, Kehlet H, Bay-Nielsen MB, Iversen MG, Wara P, Rosenberg J, Friis-Andersen HF, Jorgensen LN. Nationwide study of early outcomes after incisional hernia repair. Br J Surg. 2009 Dec;96(12):1452-7. doi: 10.1002/bjs.6728.
citation: 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.
citation: 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.