Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 21
- 主要终点
- Incisional Hernia Rate
研究概览
简要总结
Interventional, prospective, multicenter, post-marketing clinical follow-up study.
After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health.
As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.
详细描述
The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies.
Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subject has provided informed consent.
- •Subject is ≥ 18 years of age at the time of consent.
- •Subject will be undergoing an elective midline laparotomy.
- •Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:
- •High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
- •Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery
排除标准
- •Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
- •Subject for which the device is used outside the product IFU, including;
- •Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
- •Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
- •Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
- •Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
- •Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
- •Subject has participated in an investigational drug or device research study within 30 days of enrollment.
- •Subject has a life expectancy of <2 years.
- •Subject has an ASA Physical Status Classification System score >
- •Subject has >5 total risk factors or >2 high-risk factors
研究组 & 干预措施
Hernia prevention cohort
single arm safety study, no control arm
干预措施: Mesh augmented reinforcement (Device)
结局指标
主要结局
Incisional Hernia Rate
时间窗: 24 months
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
次要结局
- Surgeon Satisfaction(Day 0)
- Adverse Event(From the surgery to the 24-month visit)
- Time to Incisional Hernia Occurrence(From the surgery to the 24-month visit)
- Post-operative Pain at the Site of Surgery(Day 0, Day 1, Day 8, Month 1, Month 12, Month 24)
- Quality of Life Questionnaire (QOL) for Patient(Month 1, Month 12, Month 24)
- Patient Satisfaction(Month 12, Month 24)