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临床试验/NCT05764577
NCT05764577已完成不适用

Intraabdominal Pressure Increases Peri-operatively in Patients Undergoing DIEP Flap Reconstruction: A Prospective Study Linking High IAP to Non-fatal Lung Embolism in One Patient

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.

研究概览

简要总结

Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction.

Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Females undergoing secondary DIEP flap breast reconstruction.
  • Performance status 1-2

排除标准

  • Performance status above
  • Untreated hypertension or atrial fibrillation
  • Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.

结局指标

主要结局

Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.

时间窗: Baseline, immediate after- and 24 hours after abdominal skin closure

: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure

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

Nikolaj Warming

Principal investigator

Aalborg University Hospital

研究点 (1)

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