The objective of this study is to collect additional data on the performance and safety of the slowly-resorbable TIGR® mesh of incisional hernia prevention in patients with AAA undergoing midline laparotomy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chirurgische aandoening: Littekenbreuken, preventief
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is safety in terms of intra-operative and postoperative
complications. Intra-operatively the feasibility of the product in this setting
will be assessed, the time of implantation of the mesh will be recorded, any
problems encountered by the researcher after each procedure will be asked.
Post-operative complications including surgical site occurrence (SSO) according
to the Ventral Hernia Working Group (surgical site infection (SSI), seroma,
wound dehiscence, enterocutaneous fistula, wound cellulitis, non-healing
incisional wound, fascial disruption, skin or soft tissue ischemia, skin or
soft tissue necrosis, wound serous or purulent drainage, stitch absess, seroma,
hematoma and infected or exposed mesh), SSOs requiring a procedural
intervention (SSOPI) defined as wound opening or debridement, suture excision,
percutaneous drainage, or mesh removal. Other post-operative complications
compromise pulmonary infections and ventilation problems.
Secondary outcome
The secondary endpoints compromise the presence of incisional hernia as
determined by physical examination or ultrasonography. Size (length, width,
diameter in cm) and location of the incisional hernia will be recorded.
Location will be recorded relative to the abdomen (peri-umbilical,
infra-umbilical, supra-umbilical, or lateral), and relative to the mesh (edge
of the mesh, outside of the mesh covered area, or within the mesh covered
area). Incisional hernia is defined as any abdominal wall gap with or without
bulge in the area of a postoperative scar perceptible or palpable by clinical
examination or imaging, as determined by Korenkov et al. and accepted by the
European Hernia Society. An incisional hernia is defined as *symptomatic* if
the hernia causes pain, discomfort, incarceration, or cosmetic complaints.
Post-operative pain (VAS score) and quality of life (MOS SF-36, EQ-5D
questionnaires and Carolinas Comfort Scale) will be obtained. During follow-up
visits sensitivity of the skin in the area of the mesh placement will be
assessed.
Background summary
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.
Study objective
The objective of this study is to collect additional data on the performance
and safety of the slowly-resorbable TIGR® mesh of incisional hernia prevention
in patients with AAA undergoing midline laparotomy.
Study design
This will be a prospective, multicenter, single-arm pilot study.
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. Patients will visit the outpatient clinic at specific
time points during three years of follow-up. The visit will be managed by a
member of the study team, i.e. researcher, surgical resident or surgeon.
Intervention
An elective laparotomy through a midline incision will be performed. The
operating vascular surgeon will close the abdomen wall as described below:
First, the midline fascia will be closed with a running suture USP 2-0 PDS Plus
II (Ethicon, Somerville, NJ, USA) with *small bites* technique. With this
*small bites* technique the laparotomy wound is closed with a single layer
aponeurotic suturing technique taking tissue bites of 5 mm and intersuture
spacing of 5 mm. The ratio of suture length to wound length will be 4:1.
Subsequently, the TIGR Matrix mesh will be placed in onlay position. Therefore,
an anterior plane with a width of about 8 cm will be created between anterior
rectus fascia and subcutis.
The surgeon will use the 20 cm by 30 cm sized TIGR® Matrix mesh and adjust this
to a 6 cm by 30 cm mesh. The 6 cm by 30 cm TIGR® Matrix mesh will be placed on
the anterior rectus fascia with a bilateral overlap of 3 cm. In case of an
incision longer than 30 cm, two meshes will be tied to each other to obtain an
overlap of 3 cm. To prevent migration of the mesh and to maintain good contact
between the tissue and the mesh, the surgeon will fixate the mesh with USP 3-0
PDS Plus II (Ethicon, Somerville, NJ, USA) with intersuture spacing of 3 cm to
the abdominal wall. The subcutaneous tissue and skin will be closed with
sutures preferred by the surgeon (standard care).
Study burden and risks
The risk related to the procedure (closure of the abdominal wall with
prophylactic resorbable TIGR® Matrix mesh placement in onlay position) are
blood loss, hematoma, seroma, infection and pain. These risks are not directly
related to the product (TIGR® Matrix mesh).
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, however preserving a minimal risk of wound
dehiscence and incisional hernia.
No potential risks are known to be related to the use of this product.
Included patients will visit the outpatient clinic for five times during follow
up. During the visit to the outpatient clinic, the surgical site will be
assessed for incisional hernia, wound infection, seroma formation and other
wound problems. In three of the five visits an ultrasound of the mideline scar
will be performed. Also the patients will fill in two questionnaires (MOS
SF-36, VAS, CCS, EQ-5D questionnaires) three times during the study.
No laboratory tests will be performed.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70332.078.19 |
| Other | NL7909 |