Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Incidence of ventral hernia recurrence
研究概览
简要总结
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
详细描述
Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate.
Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.
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
- 否
入选标准
- •Male and female patients > 21 years old.
- •Able to provide informed consent in English or Spanish.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
- •Allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference.
- •Male and female patients ≤ 21 years old
- •History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up.
- •Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
结局指标
主要结局
Incidence of ventral hernia recurrence
时间窗: 2 years from study ventral hernia repair
次要结局
- Mean total cost of hospitalization for primary admission(From date of surgery to date of hospital discharge (approximately 3 days))
- Mean total cost of surgery for primary admission(during surgery)
- Time to ventral hernia recurrence(2 years from study ventral hernia repair)
- Incidence of enterocutaneous fistula formation(2 years from study ventral hernia repair)
- Mean Carolinas Comfort Scale score(2 years from study ventral hernia repair)
- Mean procedure time(during surgery)
- Mean mesh deployment time(during surgery)
- Mean total cost of narcotic usage for primary admission(From date of surgery to date of hospital discharge (approximately 3 days))
- Incidence of wound complications(90 days from study ventral hernia repair)
- Mean Visual Analog Scale score(2 years from study ventral hernia repair)
- Mean total cost of readmissions(2 years from study ventral hernia repair)