NoPro - Norwegian Hernia Prophylaxis Study

NCT06858020 | Recruiting

• 1 other identifier: 761933
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

prophylactic mesh; onlay; incisional hernia; midline laparotomy

Outcome Measures

Primary Outcomes (1)

• Incisional hernia

  Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months

  12 months

Secondary Outcomes (3)

• Quality of Life

  4-6 weeks and 1 year

• Level of pain

  4-6 weeks and 1 year

• Symptomatic surgical site occurrence (SSO)

  4-6 weeks

Study Arms (2)

Mesh group

EXPERIMENTAL

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.

Procedure: Prophylactic polypropylene onlay mesh

Suture group

NO INTERVENTION

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

Interventions

Prophylactic polypropylene onlay mesh 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.

Mesh group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery predominantly done my midline laparotomy
• Age 18 years old or older
• Written consent by patient/family
• Midline laparotomy with delayed closure

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Innlandet Hospital Trust

Hamar, Norway

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Incisional Hernia

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical

Study Officials

• Lars Martin Rekkedal, MD BBA

  Chief of surgery Hamar Hospital

  STUDY CHAIR

Central Study Contacts

Gjertrud H Kjostolfsen, MD

CONTACT

0047 90236405; gjertrud.hole.kjostolfsen@sykehuset-innlandet.no

Jorunn Skattum, MD PhD

CONTACT

0047 90236680; jorunn.skattum@sykehuset-innlandet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The radiologists who interpret the CT scans after 12 months evaluating if the patient has developed an incisional hernia
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 5, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)