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临床试验/NCT05579652
NCT05579652已完成不适用

The Change in Tension of the Abdominal Wall Tension in Open Abdomens

Benjamin T. Miller1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Change in tension over time

研究概览

简要总结

The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

详细描述

For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with an open abdomen and plan for abdominal re-exploration

排除标准

  • patients under the age of 18 years
  • pregnant patients
  • patients who have no available Legally Authorized Representative to provide consent.
  • patients with a current hernia
  • patients with a prior component separation

结局指标

主要结局

Change in tension over time

时间窗: 1.5 years

The progressive change in abdominal wall tension will be analyzed

次要结局

  • Medical care factors affecting abdominal wall tension over time(1.5 years)
  • Subject factors affecting abdominal wall tension over time(1.5 years)
  • Operative factors affecting abdominal wall tension over time(1.5 years)

研究者

发起方
Benjamin T. Miller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Benjamin T. Miller

Assistant Professor

The Cleveland Clinic

研究点 (1)

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