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临床试验/NCT04780048
NCT04780048Unknown不适用

Complex Abdominal Wall Reconstruction Using Biologic Mesh Outcomes Prospective Study

New York Medical College1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年7月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rifat Latifi

Professor, General surgery

New York Medical College

研究点 (1)

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