NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Surgery predominantly done my midline laparotomy
• Age 18 years old or older
• Written consent by patient/family
• Midline laparotomy with delayed closure
• No exclusion criteria
Locations
Other Locations
Norway
Innlandet Hospital Trust
RECRUITING
Hamar
Contact Information
Primary
Gjertrud H Kjostolfsen, MD
gjertrud.hole.kjostolfsen@sykehuset-innlandet.no
0047 90236405
Backup
Jorunn Skattum, MD PhD
jorunn.skattum@sykehuset-innlandet.no
0047 90236680
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2028-12
Participants
Target number of participants: 150
Treatments
Experimental: Mesh group
The patients in the mesh group are closed with small bites technique and in addition receiving an onlay polypropylene mesh when closing the fascia in midline laparotomies. These patients receive a subcutaneous drain to prevent seroma.
No_intervention: Suture group
The patients in the suture group are closed with small bites technique.
Related Therapeutic Areas
Sponsors
Leads: Sykehuset Innlandet HF