Comparing two methods for closing midline laparotomy incisions to prevent hernias
NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies
This study is testing if using a special mesh along with a stitching method can help prevent hernias in people who have had surgery on their abdomen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sykehuset Innlandet HF Academic / other |
| Locations | 1 site (Hamar) |
| Trial ID | NCT06858020 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial evaluates the effectiveness of using a prophylactic polypropylene mesh in addition to the small-bite suture technique for closing midline laparotomy incisions. Conducted across three hospitals in Norway, the study aims to determine whether this combined approach reduces the incidence of incisional hernias compared to the suture technique alone. Participants will be randomly assigned to one of the two closure methods, and the primary outcome will be the occurrence of incisional hernias one year post-surgery. The study seeks to enhance surgical practices in Norway by providing evidence on the use of prophylactic mesh.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for midline laparotomy who can provide informed consent.
Not a fit: Patients with a history of abdominal midline hernia mesh repair or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of incisional hernias in patients undergoing midline laparotomy, improving their quality of life.
How similar studies have performed: Previous studies have shown success with the use of prophylactic mesh in preventing incisional hernias, but this specific approach has not been widely tested in Norway.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamar
- Innlandet Hospital Trust — Hamar, Norway (Recruiting)
Study contacts
- Study coordinator: Gjertrud H Kjostolfsen, MD
- Email: gjertrud.hole.kjostolfsen@sykehuset-innlandet.no
- Phone: 0047 90236405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.