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临床试验/NCT04534920
NCT04534920Unknown不适用

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

New York Medical College1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2020年7月27日最近更新:
适应症

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

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

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

Rifat Latifi

The Felicien Steichen Professor and Chairman of Surgery

New York Medical College

研究点 (1)

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