Actively Recruiting
NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
Led by Sykehuset Innlandet HF · Updated on 2025-03-05
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating techniques to prevent incisional hernias, a common complication after midline laparotomy surgery, where abdominal contents can protrude through a surgical scar. This trial compares the use of a small-bite suture technique alone versus the same suture technique combined with an additional onlay polypropylene mesh to reinforce the abdominal wall. The study aims to improve understanding and encourage use of mesh in Norway where its use is currently limited. Participants undergoing midline laparotomy at three Norwegian hospitals will be randomly assigned to one of two groups. One group will have their abdomen closed using the small-bite suture method plus an onlay polypropylene mesh, with a subcutaneous drain to help prevent fluid buildup. The other group will receive closure using only the small-bite suture technique. The study will track outcomes after surgery to compare these approaches. Participants will be followed for one year after surgery. Researchers will assess the presence of incisional hernias using clinical exams and CT scans at 12 months. Additional assessments include surgical site complications such as hematoma, infection, seroma, and wound issues at 4 to 6 weeks post-surgery. Quality of life and pain will also be evaluated at both 4 to 6 weeks and one year. This information will help determine which closure method better reduces hernia risk and improves recovery.
CONDITIONS
Brief Title
NoPro - Norwegian Hernia Prophylaxis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgery predominantly done by midline laparotomy
- Age 18 years old or older
- Written consent by patient or family
- Midline laparotomy with delayed closure
- No exclusion criteria
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Previous abdominal midline hernia mesh repair
- Abdominal compartment syndrome
- Linea alba closure not possible
- Life expectancy under six months
- Hernia in the midline with transverse diameter larger than 2 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo midline laparotomy with fascia closure using either the small-bites technique alone or combined with an onlay polypropylene mesh.
1 surgical procedure (in-person)
Duration - 4 to 6 weeks
Participants are monitored for surgical site occurrences such as hematoma, infection, seroma, and wound dehiscence.
1 to 2 visits during 4 to 6 weeks post-surgery
Duration - Up to 12 months after surgery
Participants have their quality of life and pain levels assessed, and are evaluated for incisional hernia through clinical examination and CT scan.
Visits at 4 to 6 weeks and 1 year after surgery
Trial Site Locations
Total: 1 location
1
Innlandet Hospital Trust
Hamar, Norway
Actively Recruiting
Research Team
G
Gjertrud H Kjostolfsen, MD
J
Jorunn Skattum, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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