A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After Endovascular Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence of postoperative discomfort symptoms
研究概览
简要总结
The incidence and severity of post-procedural discomfort were evaluated in patients undergoing endovascular repair for aortic disease across six symptom-related dimensions: immobilization-related issues, puncture site discomfort, adhesive-induced skin reactions, post-stent implantation syndrome, impairment in self-care ability, and physical/psychological stress responses.
详细描述
In this study, a customized postoperative discomfort symptom assessment questionnaire was developed based on patient-reported outcomes, aiming to systematically evaluate common discomfort symptoms experienced by patients with aortic disease after endovascular intervention. The questionnaire covers six core dimensions: immobilization-related discomfort, puncture site-related discomfort, adhesive-related skin reactions, post-stent implantation syndrome, decline in self-care ability, and psychosomatic stress responses. Each symptom within these dimensions was scored on a 0-4 scale according to severity: 0 indicates no symptoms; 1 indicates mild symptoms that are tolerable; 2 indicates moderate symptoms that affect daily life but are still tolerable; 3 indicates severe symptoms requiring medical intervention; and 4 indicates extremely severe symptoms that are intolerable and require emergency treatment.
Pain was evaluated using the Numeric Rating Scale (NRS). Skin reactions such as lesions, blisters, bruises, erythema, and rashes were quantified by measuring the longest and widest parts of the lesion using a flexible measuring tape. Self-care ability was assessed using the Activities of Daily Living (ADL) scale combined with patient self-evaluation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with thoracoabdominal aortic disease
- •Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach
排除标准
- •Aortic disease caused by infection
- •Aortic disease caused by trauma
- •Aortic disease treated by open abdominal surgery
- •Presence of systemic diseases uncontrollable by current medical standards (e.g., severe cardiac, pulmonary or hepatic dysfunction; advanced malignancy; cachexia; refractory severe coronary artery disease symptoms; coagulation disorders caused by genetic diseases, etc.)
- •Patients who have undergone endovascular aortic treatment via femoral artery access prior to this procedure due to other diseases (not related to the current aortic disease)
结局指标
主要结局
The incidence of postoperative discomfort symptoms
时间窗: 6, 24, and 48 hours postoperatively
Based on six dimensions-immobilization-related, puncture site-related, adhesive-related skin reactions, aortic disease-related symptoms, self-care ability, and psychosomatic stress-patients were assessed at 6, 24, and 48 hours postoperatively using a structured questionnaire. The primary objective was to assess the incidence of postoperative complications and the severity of pain.
次要结局
未报告次要终点