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临床试验/NCT05142761
NCT05142761已完成不适用

Quantitative Tension in Posterior Component Separation for Abdominal Wall Reconstruction

Michael Rosen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月2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
100
试验地点
1
主要终点
Tension changes in posterior component separation

研究概览

简要总结

The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.

详细描述

Myofascial component separation techniques are purported to reduce tension in abdominal wall reconstruction, but few objective data exist regarding tension reduction with posterior component separation (PCS) techniques. PCS techniques include several unique steps: division of the posterior rectus sheath, division of the posterior lamella of the internal oblique aponeurosis, and transversus abdominis release. Each of these releases carries a certain amount of morbidity, including neurovascular injuries, posterior sheath breakdowns, and musculofascial disruptions resulting in lateral hernias, and thus should only be undertaken if necessary to achieve physiologic tension. More importantly, during a PCS, the surgeon must achieve posterior elements apposition in the midline to allow an adequate pocket to deploy the mesh and avoid breakdown and interstitial hernias and recurrences. Further, the anterior sheath should be reapproximated to complete a functional abdominal wall reconstruction. During each procedure, the surgeon must assess the tension on the posterior closure and decide whether further release is necessary to achieve a safe, durable repair of the posterior elements.

Demographic information, including patient age, gender, BMI, history of diabetes, chronic immunosuppression, smoking history, and history of prior ventral hernia repairs will be captured in the Abdominal Core Health Quality Collaborative (ACHQC), per the investigators' practice standard. Additional intraoperative information collected will be hernia size, extent of posterior component separation, mesh size and type, and location of mesh placement. The ACHQC is a hernia-specific, nationwide registry for quality improvement, featuring prospectively-collected, surgeon-entered data.

The aim of this study is to determine the changes in abdominal wall tension with progressive PCS in abdominal wall reconstruction. The investigators also aim to quantify the reduction in tension on both the anterior and posterior elements of a PCS.

研究设计

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

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

  • Candidates for abdominal wall reconstruction
  • Patients able to provide informed consent

排除标准

  • Patients unable to provide informed consent

结局指标

主要结局

Tension changes in posterior component separation

时间窗: Tension measurements will be recorded immediately during surgery

The tension required to bring the anterior and posterior elements of the abdominal wall to the midline after each step of the posterior component separation will be measured with a scale designed by Cleveland Clinic Mechanical Prototype machinists. The scale, hooked to a clamp on the edge of the abdominal wall, will measure tension in pounds.

次要结局

  • Short term hernia recurrences(30 days)
  • Ileus(30 days after surgery)
  • Pulmonary complications(30 days after surgery)
  • Wound Morbidity(30 days after surgery)
  • Reoperation(30 days after surgery)
  • Readmission(30 days after surgery)

研究者

发起方
Michael Rosen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Rosen

Professor of Surgery

The Cleveland Clinic

研究点 (1)

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