Review of Complex Recurrent Hernia Repair

NCT01644695 | Unknown Results DMC

• 1 other identifier: BARS
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Hernia

Keywords

BARS; Bony Anchoring Reinforcement System; Hernia; Incisional; Recurrent; abdominal wall reconstruction; abdominal wall defect; mesh; component separation

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate

  Evidence of complex incisional hernia recurrence after treatment with BARS procedure.

  ongoing, average 2.4 years

Secondary Outcomes (1)

• Intra and Post-Operative Complications

  ongoing, average 2.4 years

Study Arms (1)

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.

Procedure: Bony Anchoring Reinforcement System

Interventions

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.

Also known as: Mytec, Fasten, Marlex, Allomax, Alloderm, Strattice, Permacol

Candidate for BARS procedure.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 18 with Hernia. Included men and women, minorities, and non-english speakers.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute For Advanced Reconstruction: lead

Study Sites (1)

Institute For Advanced Reconstruction

Shrewsbury, New Jersey, 07702, United States

Location

Related Publications (6)

• 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.

  PMID: 21346524 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.

  PMID: 2143588 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.

  PMID: 20421023 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.

  PMID: 19918863 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.

  PMID: 16327650 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.

  PMID: 8310039 BACKGROUND

MeSH Terms

Conditions

Hernia; Surgical Wound; Recurrence

Interventions

Polypropylenes; AlloMax; Alloderm; strattice; Permacol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Andrew Elkwood, MD
• Organization: Institute For Advanced Reconstruction

aelkwood@hotmail.com

732-741-0970

Study Officials

• Andrew I Elkwood, MD

  Institute For Advanced Reconstruction

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 15, 2012
• Results First Posted: October 15, 2012

Record last verified: 2012-09

Locations

US (1)