Review of Complex Recurrent Hernia Repair (BARS)

September 11, 2012 updated by: Institute For Advanced Reconstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Shrewsbury, New Jersey, United States, 07702
        • Institute for Advanced Reconstruction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Alloderm
  • Strattice
  • Permacol
  • Mytec
  • Fasten
  • Marlex
  • Allomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate
Time Frame: ongoing, average 2.4 years
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
ongoing, average 2.4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra and Post-Operative Complications
Time Frame: 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.
ongoing, average 2.4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute For Advanced Reconstruction

Investigators

  • Principal Investigator: Andrew I Elkwood, MD, Institute for Advanced Reconstruction

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (ESTIMATE)

July 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BARS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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