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Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
Sponsor: University of Oulu
Summary
244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2020-04-27
Completion Date
2028-03
Last Updated
2024-02-01
Healthy Volunteers
No
Interventions
Prophylactic self gripping mesh
Prophylactic self gripping mesh, Propgrip by Medtronic.
Slowly absorbable continuous monofilament suture
Fascial closure by continuous slowly absorbable 4:1 suture
Locations (7)
Jorvi Hospital
Espoo, Finland
Helsinki University Hospital
Helsinki, Finland
Lahti Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland