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A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After Endovascular Intervention

A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After Endovascular Intervention

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07114185
Enrollment
120
Registered
2025-08-11
Start date
2026-01-01
Completion date
2027-12-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm and Dissection

Keywords

nursing, postoperative complication management

Brief summary

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.

Detailed description

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

Interventions

None listed

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with thoracoabdominal aortic disease 2. Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach

Exclusion criteria

1. Aortic disease caused by infection 2. Aortic disease caused by trauma 3. Aortic disease treated by open abdominal surgery 4. 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.) 5. 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)

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative discomfort symptoms6, 24, and 48 hours postoperativelyBased 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.

Countries

China

Contacts

Primary Contactxiaoya zhang
2470575102@qq.com+8613516729415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026