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Review of Complex Recurrent Hernia Repair

Conditions
Recurrent Hernia
Interventions
Procedure: Bony Anchoring Reinforcement System
Registration Number
NCT01644695
Lead Sponsor
Institute For Advanced Reconstruction
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
85
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Candidate for BARS 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.
Primary Outcome Measures
NameTimeMethod
Recurrence Rateongoing, average 2.4 years

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

Secondary Outcome Measures
NameTimeMethod
Intra and Post-Operative Complicationsongoing, 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.

Trial Locations

Locations (1)

Institute For Advanced Reconstruction

🇺🇸

Shrewsbury, New Jersey, United States

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