NCT06762561招募中不适用
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of incisional hernias
研究概览
简要总结
The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:
- Does mesh reinforcement reduce the incidence of incisional hernias?
- What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.
Participants will:
- Undergo clinical follow-ups and abdominal ultrasounds to detect IH.
- Complete quality-of-life questionnaires (EQ-5D and PROMIS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
- •Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
- •Attendance at a clinical follow-up examination at least one year after the procedure
- •General informed consent signed for the use of medical data for research purposes
排除标准
- •Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
- •Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
- •Patients who did not attend the required clinical follow-up examination at least one year postoperatively.
结局指标
主要结局
Rate of incisional hernias
时间窗: january-april 2025
Incisional hernia will be evaluated trough clinical examination and ultrasound assessement
次要结局
- Rate of fascial dehiscence(january-april 2025)
- Rate of seromas(january-april 2025)
- Rate of surgical site infection(january-april 2025)
- Rate of hematomas(january-april 2025)
- Operative time(january-april 2025)
研究者
研究点 (1)
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