Incisional Hernias Clinical Trial
Official title:
Mesh Implantation for Prophylaxis of Incisional Hernia
Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such
meshes are mainly implanted via open or laparoscopic approach. The differential impact of
these two types of surgical technique on recurrence rate will be investigated with this
study.
With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia
repair will be investigated prospectively. Hernia recurrence is the main outcome measure.
Background
Incisional hernia is one of the most common complication in general abdominal surgery. An
overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of
patients with selected risk factors such as obesity.
In the general surgical patient the current standard is the closure of the abdominal wall
using a running, slowly absorbable suture. With this well established clinical practice the
incidence remains high and incisional hernia repair must be performed frequently in order to
treat patients`symptoms and to prevent progression of the hernia an possible complications.
Consequently, in high risk patients prophylactic mesh implantation is performed routinely in
our institution.
Objective
- Occurrence of at least two of the following factors:
- Male gender
- Malignant tumor present
- Body mass index above 25kg/m2
- Previous laparotomy
- Elective operation
- Patient >18 years
- Written informed consent
Methods
Prospective,two armed, controlled, randomized study
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02730936 -
Antimicrobial Hernia Repair Device
|
N/A |