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ID
Source
Brief title
Health condition
Prevention of incisional hernia in high-risk patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to examine the effectiveness of incisional hernia prevention with synthetic, slowly-resorbable TIGR® Matrix mesh placement in patients with AAA undergoing midline laparotomy.
Secondary outcome
The secondary objectives are to measure relevant postoperative complications, postoperative pain, sensitivity of the skin in the area of the mesh placement and quality of life.
Background summary
Rationale: Incisional hernia is one of the most frequent long-term complications after midline surgery, especially in high-risk groups such as patients with an abdominal aortic aneurysm (AAA). To prevent incisional hernias and potentially subsequent complications as strangulation and incarceration a prophylactic mesh can be placed. Usually a non-resorbable mesh is used. However, the advantage of a resorbable mesh is that the foreign material persisting in the patient is reduced, without compromising on the initial biomechanical resistance of the mesh. Therefore, this study will examine the effectiveness of synthetic, slowly-resorbable TIGR® Matrix mesh in preventing incisional hernias after laparotomy in patients with AAA.
Objective: The primary objective is to examine the effectiveness of synthetic, slowly resorbable TIGR® Matrix mesh in preventing incisional hernias in patients with AAA that undergo midline laparotomy.
Study design: Prospective, multicenter, single-arm trial.
Study population: Patients of 18 years or older, with AAA undergoing an elective midline laparotomy.
Intervention: During closure of the abdominal wall, TIGR® Matrix Mesh will be placed in onlay position to prevent incisional hernia.
Main study parameters/endpoints: The primary endpoint is the presence of incisional hernia after 3 years of follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The potential benefits of this fully resorbable mesh compared to the non-resorbable meshes are a possible reduced risk of seroma formation, infection and persistent pain, while preserving a reduced risk of wound dehiscence and incisional hernia.
Study objective
Reinforcement with prophylactic slowly-resorbable TIGR Matrix mesh in high-risk patients undergoing midline laparotomy is effective.
Study design
30 days, 3 months, 1 year, 2 years and 3 years
Intervention
Patients with an AAA undergoing an elective midline laparotomy will receive closure of the fascia with the aid of a prosthetic mesh. Patients will receive prophylactic mesh augmentation with synthetic, slowly-resorbable TIGR® Matrix mesh in onlay position.
Inclusion criteria
- Elective midline laparotomy for patients with Abdominal Aortic Aneurysm.
- Age ≥ 18 years.
- Signed informed consent by patient.
Exclusion criteria
- Pregnancy.
- Emergency procedures.
- Inclusion in other trials with interference of the primary endpoint.
- Life expectancy less than 24 months (as estimated by the attending physician).
- Immune suppression therapy within 2 weeks before surgery.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7909 |
| CCMO | NL70332.078.19 |
| OMON | NL-OMON56842 |