Recurrent HerniaBARSNCT01644695
Review of Complex Recurrent Hernia Repair
An observational study of Recurrent Hernia, run by Institute For Advanced Reconstruction at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Hernia
- What is being tested?
- Bony Anchoring Reinforcement System
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 with Hernia. Included men and women, minorities, and non-english speakers.
Who may be able to join
- Patients with recurrent abdominal wall incisional hernias
- Age > 18
- No medical contraindications to immunosuppressive therapy (in cases utilizing allograft)
- Ability and motivation to follow up appropriately
- Ability and motivation to adhere to rehabilitation regimen
- Stable sequelae of initial CNS insult
Who cannot join
- Pregnancy
- Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and interfere with follow-up.
- Patient unable to tolerate surgery, rehabilitation, or immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute For Advanced Reconstruction
Shrewsbury, New Jersey, 07702
About this study
Official title: Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)
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.
Read the 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.
- Conditions
- Recurrent Hernia
- Being tested
- Bony Anchoring Reinforcement System
- Keywords
- BARS, Bony Anchoring Reinforcement System, Hernia, Incisional, Recurrent, abdominal wall reconstruction, abdominal wall defect, mesh, component separation
- Medical subject headings
- Hernia, Surgical Wound, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bony Anchoring Reinforcement SystemProcedure or surgery
Also called Mytec, Fasten, Marlex, Allomax
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bony Anchoring Reinforcement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
Measured: ongoing, average 2.4 years
Secondary outcomes (1)
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.
Measured: ongoing, average 2.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Recurrent HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute For Advanced Reconstruction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew I Elkwood, MD, Principal investigator, Institute For Advanced Reconstruction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644695
- Sponsor's protocol ID
- BARS
- Acronym
- BARS
- Status last verified
- Sep 2012
- First submitted
- 17 Jul 2012
- Last updated
- 15 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21346524Ramirez 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.
PubMed 2143588Hawn 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.
PubMed 20421023Bisgaard 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.
PubMed 19918863Sisco 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.
PubMed 16327650Francis 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.
PubMed 8310039
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)
- ClinicalTrials.gov ID
- NCT01644695
- Acronym / sponsor ID
- BARS / BARS
- Conditions
- Recurrent Hernia
- Keywords
- BARS, Bony Anchoring Reinforcement System, Hernia, Incisional, Recurrent, abdominal wall reconstruction, abdominal wall defect, mesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Institute For Advanced ReconstructionUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 15 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidate for BARS procedure. | – | Procedure: Bony Anchoring Reinforcement SystemThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 with Hernia. Included men and women, minorities, and non-english speakers.
Key inclusion criteria (6 listed)
- Patients with recurrent abdominal wall incisional hernias
- Age > 18
- No medical contraindications to immunosuppressive therapy (in cases utilizing allograft)
- Ability and motivation to follow up appropriately
- Ability and motivation to adhere to rehabilitation regimen
Key exclusion criteria (3 listed)
- Pregnancy
- Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and interfere with follow-up.
- Patient unable to tolerate surgery, rehabilitation, or immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bony Anchoring Reinforcement SystemAlso: Mytec, Fasten, Marlex, AllomaxAbdominal 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. | Procedure or surgery | Candidate for BARS procedure. |
Primary outcome
Recurrence Rate
Time frame: ongoing, average 2.4 years
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
1 secondary outcome
Intra and Post-Operative Complications
Time frame: ongoing, average 2.4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21346524Tong 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.
- Background: PubMed 2143588Ramirez 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.
- Background: PubMed 20421023Hawn 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.
- Background: PubMed 19918863Bisgaard 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.
- Background: PubMed 16327650Sisco 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.
- Background: PubMed 8310039Francis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew I Elkwood, MD principal investigator
Institute For Advanced Reconstruction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Hernia, run by Institute For Advanced Reconstruction at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate (time frame: ongoing, average 2.4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644695, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.