Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Incidence of incisional hernia
Study Overview
Brief Summary
The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.
Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.
Detailed Description
Prospective randomized controlled study with two study arms.
Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.
Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)
After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.
Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient scheduled for elective or early elective open repair of aortic aneurysm
Exclusion Criteria
- •Emergency surgery
- •EVAR (endovascular procedure)
- •Patients with previous midline laparotomy
- •Patients with in situ abdominal mesh after previous hernia repair
- •Patients with large diastasis of abdominal wall
- •Allergy to penicillin
- •Women before menopause (mesh can interfere with potential future pregnancies)
Arms & Interventions
Mesh implantation
Ultrapro® Mesh implantation
Intervention: Ultrapro® Mesh implantation (Device)
Standard wound closure without a mesh
Standard wound closure
Intervention: Standard wound closure (Other)
Outcomes
Primary Outcomes
Incidence of incisional hernia
Time Frame: 24 months
Secondary Outcomes
- operation time(4 hours)
- Rate of adverse events(24 months)
- Rate of postoperative complications(7 days)
Investigators
Ignazio Tarantino
M.D.
Cantonal Hospital of St. Gallen