Hernia Incisional, Incision Site Complication
Conditions
Brief summary
he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is: will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer?
Interventions
PROCEDUREmesh placement
mesh is placed in retromuscular space when abdominal wall is closed
OTHERconventional abdominal wall closure without mesh
conventional AWC without mesh
Sponsors
Juan Bellido-Luque.MD
Hospital Universitario Virgen Macarena
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
Yes
Inclusion criteria
* Patients aged 18 years or older. * Elective conventional or extensive right subcostal laparotomy. * Two or more risk Factor for incisional hernia (IH): \> 60 years, Body Mass Index \> 27 kg/m2, Diabetes Mellitus, pulmonary/liver/renal disease, malignancy, preoperative chemotherapy, immunosuppression or smoking5. * Life expectancy of at least 12 months. * Signed informed consent with agreement to attend all study visits.
Exclusion criteria
* Emergency surgery. * Previous right subcostal hernia or right subcostal incision. * Metastatic disease or irresectable malignancy identified during the surgery with life expectancy less than 12 months. * Active abdominal infection at the time of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| image detected IH rate | 12 and 24 months | incisional hernia rate after 12 and 24 posoperative months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incision types | day 1 (surgical procedure) | types of incisions used |
| postoperative complications | 3-6-12-24 postoperative months | complications after surgical procedure |
Countries
Spain
Outcome results
None listed