NCT01644695

Review of Complex Recurrent Hernia Repair

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Institute For Advanced Reconstruction · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Hernia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2012-07-19
• Last updated: 2012-10-15
• Results posted: 2012-10-15

Locations

1 site across 1 country: United States