Complex Abdominal Wall Reconstruction Using Biologic Mesh Outcomes Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- In Hospital Complications
研究概览
简要总结
The purpose of this study is to determine how the patient factors, co-morbid conditions, pre-operative workup, anatomy of the defect, reconstruction details, operative techniques, and type of repairs contribute to the final outcome of abdominal wall reconstruction. The outcomes of interest are: in-hospital complications, discharge disposition, hospital and ICU length of stay, long term follow-up (recurrence, reoperation, and explantation rates).
详细描述
Background:
Abdominal wall defects are commonly seen in trauma and EGS patients. During the last decade numerous advances have been made in the management of patients with abdominal wall defects. These defects are repaired by various surgical techniques including mesh repair (synthetic vs. biologic), primary repair, etc. However, the outcomes of patients after these injuries are highly variable and many of these patients suffer from in-hospital complications, mesh infections requiring explantation, and recurrence. Various factors play a role in the final outcome of the patient. These include factors associated with the initial surgery or disease (trauma or emergency general surgery), patient demographics (age, gender, co-morbidities), preoperative features (hemoglobin and laboratory parameters), technique of repair (onlay, inlay, retro rectus) and the types of mesh used. However, the role of each of these factors in the final outcome of patients remains unclear in the literature.
Study Design Study Type: Observational Observational Study Model: Cohort Time Perspective: Prospective Enrollment: 250 Number of Groups/Cohorts: 1
Recruitment Procedures:
Attending physicians will discuss possible participation in the study with patients who meet initial screening criteria and have been scheduled for abdominal wall repair/ventral hernia repair. If a patient agrees, they will be approached by our research coordinator to discuss consenting. The research coordinator will introduce herself and her role with Westchester Medical Center, and read the following script. A translator for Spanish speaking patients will be available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 years and above undergoing Abdominal wall reconstruction with biological mesh.
排除标准
- •Vulnerable patient population (Neonates, Prisoners, Pregnant) will not be included in our study
结局指标
主要结局
In Hospital Complications
时间窗: 3 years
Infection, re-procedures, explantation rates, length of hospital stay and ICU stay.
次要结局
未报告次要终点
研究者
Rifat Latifi
Professor, General surgery
New York Medical College
