Incisional Hernia
Conditions
Brief summary
Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
Interventions
DEVICEMesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
Sponsors
Kantonsspital Liestal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Median Laparotomy
Exclusion criteria
* Bowel perforation * Pregnancy * Palliative surgery * Drug abuse * Age under 18 * Mental disability * Allergy to mesh components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | 2 years | Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. | 5 Years | Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Mesh The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath). | 136 |
| Mesh Implementation Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. | 131 |
| Total | 267 |
Baseline characteristics
| Characteristic | No Mesh | Mesh Implementation | Total |
|---|---|---|---|
| Age, Customized | 65.1 years STANDARD_DEVIATION 2 | 64.1 years STANDARD_DEVIATION 2.3 | 64.5 years STANDARD_DEVIATION 2 |
| Region of Enrollment Switzerland | 136 participants | 131 participants | 267 participants |
| Sex: Female, Male Female | 80 Participants | 71 Participants | 151 Participants |
| Sex: Female, Male Male | 56 Participants | 60 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 136 | 4 / 131 |
| other Total, other adverse events | 0 / 136 | 2 / 131 |
| serious Total, serious adverse events | 0 / 136 | 0 / 131 |
Outcome results
Primary
Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy
Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Mesh | Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | 40 participants |
| Mesh Implementation | Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | 18 participants |
Secondary
Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.
Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.
Time frame: 5 Years