Incisional Hernia
Conditions
Brief summary
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%. The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly. The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe . With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.
Interventions
PROCEDUREStrattice
Intra-abdominally Fixation
PROCEDURESingle running suture of abdominal fascia
Intra-abdominal suture
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing emergency midline laparatomy * Emergency laparoscopy with expected conversion to midline laparatomy * Written informed consent
Exclusion criteria
* ASA ≥5 * Septic shock * Pregnant women * Prior mesh Implantation * Known sensitivity for porcine material or Polysorbate 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incidence of death | up to 18 months | follow-up |
| Number of patients with hernia free survival | up to 18 months | follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of surgical site infections postoperative | 30 days | follow-up |
| Number of postoperative intestinal fistulas | 30 days | follow-up |
| Number of small bowel obstructions | 18 months | follow-up |
| Number of patients with postoperative fascial dehiscence | 30 days | follow-up |
| Number of postoperative mesh infections | 18 months | follow-up |
| Number of postoperative mesh explantations | 18 months | follow-up |
| Number of patients with postoperative pain | 18 months | follow-up |
| Number of postoperative mortality | 90 days | survival |
Countries
Switzerland
Outcome results
None listed