Incisional Hernia
Conditions
Keywords
Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications
Brief summary
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the gold-standard for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair. The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
Interventions
DEVICEImplant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Sponsors
Cirujanos la Serena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2) * First repair * Older than 35 years of age and younger than 75 years of age * Both genders * Any BMI * Only upper abdominal midline incisional hernias (supraumbilical) * Patients submitted only to elective repair
Exclusion criteria
* Recurrent incisional hernia * Emergency surgery * Hernias with a diameter higher than 5 cm or more than 25 cm2 of area * Lower midline abdominal incisional hernias * Other hernias rather than midline incisional hernias * Non-incisional hernias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term recurrence | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Short-term complications | 1 year |
Countries
Chile
Outcome results
None listed