NoPro - Norwegian Hernia Prophylaxis Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prophylactic polypropylene onlay mesh.
- Who it may be relevant to
- Registry conditions: Incisional Hernia After Midline Laparotomy, Quality of Life (QOL), Burst Abdomen, Surgical Site Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
Overview
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.
Detailed description
An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.
The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.
The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.
Interventions
- Procedure Prophylactic polypropylene onlay mesh
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.
Primary outcome measures
- Incisional hernia [Time frame: 12 months]
Secondary outcome measures (3)
- Quality of Life [Time frame: 4-6 weeks and 1 year]
- Level of pain [Time frame: 4-6 weeks and 1 year]
- Symptomatic surgical site occurrence (SSO) [Time frame: 4-6 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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 lager than 2 cm
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Norway · 1 center
- Innlandet Hospital Trust — Hamar
Identifiers
NCT: NCT06858020 · 761933