Repair of Complex Recurrent Incisional Hernias With The Bony Anchoring Reinforcement System (BARS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Recurrence Rate
研究概览
简要总结
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.
详细描述
• 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent abdominal wall incisional hernias
- •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
排除标准
- •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.
结局指标
主要结局
Recurrence Rate
时间窗: ongoing, average 2.4 years
Evidence of complex incisional hernia recurrence after treatment with BARS procedure.
次要结局
- Intra and Post-Operative Complications(ongoing, average 2.4 years)