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ACTIVE NOT RECRUITING
NCT04311788
NA

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

View on ClinicalTrials.gov

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

DEVICE

Prophylactic self gripping mesh

Prophylactic self gripping mesh, Propgrip by Medtronic.

DEVICE

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