Recurrent Hernia
Conditions
Keywords
BARS, Bony Anchoring Reinforcement System, Hernia, Incisional, Recurrent, abdominal wall reconstruction, abdominal wall defect, mesh, component separation
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.
Interventions
PROCEDUREBony 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.
Sponsors
Institute For Advanced Reconstruction
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | ongoing, average 2.4 years | Evidence of complex incisional hernia recurrence after treatment with BARS procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Candidate for BARS Procedure. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants |
| Age Continuous | 53.25 years STANDARD_DEVIATION 10.22 |
| Region of Enrollment United States | 85 participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 85 |
| serious Total, serious adverse events | 0 / 85 |
Outcome results
Primary
Recurrence Rate
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
Time frame: ongoing, average 2.4 years
Population: Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candidate for BARS Procedure. | Recurrence Rate | 3 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.
Time frame: ongoing, average 2.4 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candidate for BARS Procedure. | Intra and Post-Operative Complications | 27 participants |