No Clear Benefit With the Use of Onlay Mesh by Vascular Surgeons for Incisional Hernia Prevention in Patients With Abdominal Aortic Aneurysm Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of Incisional Hernia
研究概览
简要总结
The aim of the study was to compare the incidence of IH after abdominal aortic aneurysm (AAA) open repair according to the abdominal wall closure technique used. The main question it aims to answer is: Does prophylactic mesh reinforcement prevents from IH after AAA open repair?
Patients were divided in 2 groups, fascial closure with small bites and prophylactic mesh reinforcement (Group A); and primary fascial closure with small bites alone (Group B) and were performed a clinical examination at least once within the first 24 post-operative months, where the clinical diagnosis of IH could be evaluated.
详细描述
This study included patients treated for AAA between January 2019 and December 2021 in our institution. The study was performed according the principles established in the Declaration of Helsinki and the good clinical practice (GCP) guidelines of the International Committee on Harmonization (ICH).
Two groups were evaluated, group A where patients were treated by small-bites closure plus PMR (onlay mesh) and group B where patients received primary closure with small-bites alone.
Given the observational, cross-sectional design of the study, no matching, stratification, or multivariate adjustment was applied to mitigate baseline differences between groups.
Inclusion criteria was: Patients who had open aortic surgery for AAA during the study period and gave their informed consent to participate in the study.
Urgent AAA repair, patients treated for infective aortic aneurysms and different access to midline laparotomy were established as exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients who had open aortic surgery for AAA during the study period and gave their informed consent to participate in the study.
排除标准
- •Urgent AAA repair
- •Patients treated for infective aortic aneurysms.
- •Different access to midline laparotomy.
研究组 & 干预措施
Prophylactic mesh reinforcement
Patients were treated by small-bites closure plus prophylactic mesh reinforcement (onlay mesh). The mesh used was monofibrilar, non-absorbable and made of polypropylene and was fixed by simple stiches in an onlay position.
干预措施: Abdominal Ultrasound or computed tomography (Diagnostic Test)
Primary closure
Patients received primary fascial closure with small-bites alone.
干预措施: Abdominal Ultrasound or computed tomography (Diagnostic Test)
结局指标
主要结局
Presence of Incisional Hernia
时间窗: 0-2 years.
Presence of IH during follow-up in both groups and a comparison between both groups represented in a Kaplan meier curve
次要结局
- Wound complications.(0-2 years)
- Surgical Hospitalization times(0-2 years)
- Reintervention due to IH(0-2 years)
研究者
Marta Fernández Reyes
Doctor
Hospital Universitario Ramon y Cajal