NoPro - Norwegian Hernia Prophylaxis Study

Sykehuset Innlandet HF

Status: Enrolling

Conditions: Quality of Life (QOL); Incisional Hernia After Midline Laparotomy; Surgical Site Infections; Burst Abdomen

Treatments: Procedure: Prophylactic polypropylene onlay mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06858020

761933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Mesh group

Experimental group

Description:

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.

Treatment:

Procedure: Prophylactic polypropylene onlay mesh

Suture group

No Intervention group

Description:

The patients in the suture group are closed with small bites technique.