Comparison of Sample Characteristics Between the Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction at Westchester Medical Center vs Americas Hernia Society Quality Collaborative (AHSQC) Registry Dataset
试验速览
- 阶段
- 不适用
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients
研究概览
简要总结
Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
详细描述
Abdominal wall defects or hernias are commonly seen after open surgery performed electively or under emergent conditions. 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 reasons for initial surgery or disease (trauma or emergency general surgery), patient demographics (age, gender, co-morbidities), preoperative features (hemoglobin and other biochemical indicators, surgical technique used during the repair and use of repair (onlay, inlay, retro rectus) and the types of mesh used.
Study Design Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Primary Objective: To determine the degree to which our sample of Strattice® recipients resemble AHSQC Strattice® recipients.
Study Summary:
This study involves two different datasets from our existing studies L#12083 and L#12,086 which are approved by New York Medical College, IRB on 6/14/2017and 7/7/2017 respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 85 years old
- •Subjects who had complex abdominal wall reconstruction and received biologic mesh are included in the study
排除标准
- •Subjects below 18 years of age and above the age of 85 years are excluded.
- •Any hernia repair not using biologic mesh are excluded.
结局指标
主要结局
comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients
时间窗: from 1/1/2011 to 12/31/2018
Comorbidities, operative details, mesh size and location, number of drains, surgical site infection and readmissions.
次要结局
未报告次要终点
研究者
Rifat Latifi
The Felicien Steichen Professor and Chairman of Surgery
New York Medical College
