Review of Complex Recurrent Hernia Repair

Recurrent Hernia Clinical Trial

— BARS  

Official title:

Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01644695
• Other study ID #: BARS
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 17, 2012
• Last updated: September 11, 2012
• Start date: October 2011
• Est. completion date: January 2020

Study information

• Verified date: September 2012
• Source: Institute For Advanced Reconstruction
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 85
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Hernia
• Recurrent Hernia

Intervention

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.

Locations

Country	Name	City	State
United States	Institute For Advanced Reconstruction	Shrewsbury	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Institute For Advanced Reconstruction

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Sisco M, Dumanian GA. A simple technique to anchor prosthetic mesh to bone. Plast Reconstr Surg. 2005 Dec;116(7):2059-60. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rate	Evidence of complex incisional hernia recurrence after treatment with BARS procedure.	ongoing, average 2.4 years	No
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.	ongoing, average 2.4 years	Yes