Clinical trial NCT06858020: NoPro - Norwegian Hernia Prophylaxis Study
Official title: NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia After Midline Laparotomy
Quality of Life (QOL)
Burst Abdomen
Surgical Site Infections
Keywords: prophylactic mesh
onlay
incisional hernia
midline laparotomy
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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

Primary outcomes:
measure: Incisional hernia
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 4-6 weeks and 1 year
measure: Level of pain
timeFrame: 4-6 weeks and 1 year
measure: Symptomatic surgical site occurrence (SSO)
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Hamar
country: Norway
facility: Innlandet Hospital Trust
Study officials:
affiliation: Chief of surgery Hamar Hospital
name: Lars Martin Rekkedal, MD BBA
role: STUDY_CHAIR
References: