Comparing two types of mesh for repairing incisional hernias
Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
This study is testing which type of mesh, Ventralex or Progrip, works better for repairing midline incisional hernias to see which one helps patients recover faster and reduces the chance of the hernia coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Karlskoga and 1 other locations) |
| Trial ID | NCT04358159 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares the effectiveness of Ventralex patch and Progrip mesh in the surgical repair of midline incisional hernias. The study aims to evaluate the outcomes of these two mesh types in terms of recurrence rates and overall patient recovery. Participants will be randomly assigned to receive either the Ventralex mesh placed in a sublay position or the Progrip mesh used in an onlay technique. The trial focuses on patients with specific criteria related to hernia size and body mass index.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 100 with a midline incisional hernia defect size between 1-4 cm and a BMI of less than 35.
Not a fit: Patients with defect sizes greater than 4 cm, ongoing pregnancy, a BMI over 35, or primary hernias will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective mesh type for incisional hernia repair, potentially leading to better surgical outcomes for patients.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of different mesh types in hernia repair, indicating that this trial could contribute valuable data to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hernia defect 1-4 cm * Incisional hernia or recurrent hernia after previous primary hernia repair * BMI \<35 * Age 18-100 years Exclusion Criteria: * Defect size\>4 cm * Ongoing pregnancy * BMI\>35 * Primary hernia
Where this trial is running
Karlskoga and 1 other locations
- Karlskoga Hospital — Karlskoga, Sweden (Not_yet_recruiting)
- Karlskoga Hospital — Karlskoga, Sweden (Recruiting)
Study contacts
- Principal investigator: Gabriel Sandblom, MD — Karolinska Institutet
- Study coordinator: Gabriel Sandblom, MD, PhD
- Email: gabriel.sandblom@ki.se
- Phone: +4686162362
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.