Prophylactic Mesh Implantation after Abdominal Aortic Aneurysm Repair.A prospective, randomised, controlled study.

Not Applicable

• Conditions: Abdominal Aortic Aneurysm; I71.4; Abdominal aortic aneurysm, without mention of rupture

• Registration Number: DRKS00003379
• Lead Sponsor: niversitätklinikum Hamburg-EppendorfUniversitäres Herzzentrum Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Male and female patients >18 years of age.

2. Patients undergoing an elective surgery for AAA repair.

3. Patients who currently have no malignant disease requiring therapy.

4. Patients who are able to fulfill all clinical investigation requirements

5. Patients who have provided written informed consent.

Exclusion Criteria

1. Patients who require median laparotomy for AAA repair as an emergency procedure.

2. Expected length of fascia incision > 30 cm.

3. Patients with coagulopathy

4. Patients who have had previous median laparotomy and/or laparaotomy crossing the incision necessary for AAA laparotomy.

5. Patients with current immunsuppressive therapy (>40 mg corticoid/day or azathioprine).

6. Chemotherapy within the last 4 weeks.

7. Radiotherapy on the treated region within the last 2 months.

8. Pregnant and breast-feeding women.

9. Known allergy against ingredients of the investigational products (polypropylene, poly-4-hydroxybutyrate, polydioxanone).

10. Patients participating in other investigational drug or medical device studies within the preceding 4 weeks.

11. Patients with an ongoing medical condition or social reason that may affect their ability to complete the two years follow-up period.

12. Life expectancy less than 24 months.

13. Severe psychiatric or neurologic disease.

14. Lack of compliance.

15. Drug abuse.

16. Inability to understand and follow the instructions given by the investigator (e.g. dementia, lack of time, insufficient command of language).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Herniation rate 24 months after Intervention (verified by clinical examination and confirmed by Ultrasound).