Assessment of the Ability to Predict Fascial Closure Using Shear-wave Elastography in Patients With Midline Incisional Hernias.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Correlate SWE Assessment to Tensiometer (Specific Aim 3)
研究概览
简要总结
Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR.
Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure.
Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension.
详细描述
Shear wave elastography can be used to predict abdominal wall compliance pre-operatively and can therefore be used as a tool to improve surgical outcomes.
Specific Aim 1:
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology.
Specific Aim 2:
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 y/o.
- •Midline ventral / incisional hernia.
- •Plan for open retromuscular incisional hernia repair.
排除标准
- •Prior VHR with mesh.
- •Isolated subxiphoid (European Hernia Society (EHS) classification M1) or suprapubic hernias (EHS classification M5)
- •History of flank incisions. M1 (midline position 1) is defined as the xiphoid process down to a point 3cm below the xiphoid. M5 (midline position 5) is defined as the pubis to a point 3cm above the pubis.
- •Infected / contaminated cases.
- •Plan for robotic, laparoscopic, or open onlay repair, or plan for primary (non-mesh) repair.
研究组 & 干预措施
Control Group 1
Control group 1 patients will have no incisional hernia or prior laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points
干预措施: Imaging: Ultrasound (Procedure)
Control Group 2
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points .
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral
Tensiometry For all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure.
干预措施: Elective Midline Laparotomy (Procedure)
Control Group 2
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points .
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral
Tensiometry For all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure.
干预措施: Imaging: Ultrasound (Procedure)
Control Group 2
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points .
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral
Tensiometry For all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure.
干预措施: Tensiometry (Other)
结局指标
主要结局
Correlate SWE Assessment to Tensiometer (Specific Aim 3)
时间窗: Study participation ends after surgery
Correlate SWE-determined elasticity of abdominal wall to intraoperative assessment of tension required to achieve fascial closure using Tensiometry.
Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1)
时间窗: Study participation ends after surgery
Determine the elasticity of abdominal wall muscles (rectus abdominis, external oblique, internal oblique, and transversus abdominis) through shear wave elastography in patients with midline incisional hernias of varying complexity and morphology using Ultrasound measurements.
Correlate Elastography measurements with MFR (Specific Aim 2)
时间窗: Study participation ends after surgery
Correlate shear wave elastography measurements of the abdominal wall with the extent of MFR required to achieve fascial closure using Ultrasound measurements.
次要结局
未报告次要终点