CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 85 enrolled
Drug / intervention
Bony Anchoring Reinforcement Systemprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01644695
NCT01644695N/AUnknown

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

Institute For Advanced Reconstruction·observational·Posted Jul 19, 2012·Updated Oct 15, 2012

In Brief

An observational study evaluating Bony Anchoring Reinforcement System for Recurrent Hernia. Targeting 85 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/AUnknownOverdue
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2012
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 14.0 years ago

Interventions

Bony Anchoring Reinforcement Systemprocedure

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.