Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
• Overview of Research
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bony Anchoring Reinforcement System | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate | Evidence of complex incisional hernia recurrence after treatment with BARS procedure. | ongoing, average 2.4 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria: Minors
Not provided
Not provided
Over 18 with Hernia. Included men and women, minorities, and non-english speakers.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew I Elkwood, MD | Institute For Advanced Reconstruction | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute For Advanced Reconstruction | Shrewsbury | New Jersey | 07702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21346524 | Background | 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. | |
| 2143588 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence Rate | Evidence of complex incisional hernia recurrence after treatment with BARS procedure. | Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation. | Posted | Number | participants | ongoing, average 2.4 years |
|
Adverse event data was collected with regular, ongoing follow up visits. Average time was 2.4 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | No participant was excempt from this measure. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | 6 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Elkwood, MD | Institute For Advanced Reconstruction | 732-741-0970 | aelkwood@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D006547 | Hernia |
| D000072836 | Surgical Wound |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D011126 | Polypropylenes |
| C000617887 | AlloMax |
| C440568 | Alloderm |
| C568444 | strattice |
| C422414 | Permacol |
| ID | Term |
|---|---|
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 20421023 | Background | 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. |
| 19918863 | Background | 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. |
| 16327650 | Background | 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. |
| 8310039 | Background | 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total. | Posted | Number | participants | ongoing, average 2.4 years |
|
|
|
| 0 |
| 85 |
| 27 |
| 85 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Around injury site. |
|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DVT | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Neuroma | Nervous system disorders | Systematic Assessment |
|
| Infected Mesh | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Drain Issue | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Entrapped Nerve | Nervous system disorders | Systematic Assessment |
|
| Neuralgia Paresthetica | Nervous system disorders | Systematic Assessment |
|
| Further Surgery Required | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| D010335 | Pathologic Processes |
| D009930 |
| Organic Chemicals |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |