Study Results
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View full resultsBasic Information
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UNKNOWN
85 participants
OBSERVATIONAL
2011-10-31
2020-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
Study Groups
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Candidate for BARS procedure.
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.
Bony Anchoring Reinforcement System
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.
Interventions
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Bony Anchoring Reinforcement System
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Institute For Advanced Reconstruction
OTHER
Responsible Party
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Principal Investigators
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Andrew I Elkwood, MD
Role: PRINCIPAL_INVESTIGATOR
Institute For Advanced Reconstruction
Locations
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Institute For Advanced Reconstruction
Shrewsbury, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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BARS
Identifier Type: -
Identifier Source: org_study_id