NoPro - Norwegian Hernia Prophylaxis Study

NCT ID: NCT06858020

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2028-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Mesh group

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.

Group Type: EXPERIMENTAL

Prophylactic polypropylene onlay mesh

Intervention Type: PROCEDURE

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.

Suture group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Innlandet HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Martin Rekkedal, MD BBA

Role: STUDY_CHAIR

Chief of surgery Hamar Hospital

Locations

Innlandet Hospital Trust

Hamar, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Gjertrud H Kjostolfsen, MD

Role: CONTACT

gjertrud.hole.kjostolfsen@sykehuset-innlandet.no

0047 90236405

Jorunn Skattum, MD PhD

Role: CONTACT

jorunn.skattum@sykehuset-innlandet.no

0047 90236680

Facility Contacts

Lars Martin Rekkedal, MD BBA

Role: primary

lars.martin.rekkedal@sykehuset-innlandet.no

0047 90041959

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

761933

Identifier Type: -

Identifier Source: org_study_id