Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06858020

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

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)

Post-operative Follow-up

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

Follow-up Assessments

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

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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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