Comparing suture mesh and planar mesh for small ventral hernia repair
Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
This trial will test whether using mesh-suture instead of planar mesh during repair of small ventral hernias in adults leads to fewer wound problems, better quality of life, and shorter operation times.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regionshospital Nordjylland Government |
| Locations | 1 site (Hjørring) |
| Trial ID | NCT07476560 on ClinicalTrials.gov |
What this trial studies
Adult patients with small ventral hernias (maximum 3 × 3 cm on imaging) are randomized to repair with either mesh-suture or standard planar mesh. Baseline clinical data and quality-of-life (QoL) scores are collected before surgery, and patients return for a wound inspection and ultrasound on postoperative day 7–13. QoL is re-measured at 90 days and operation time and wound complication rates are recorded as key outcomes. Results will directly compare complication rates, patient-reported QoL, and operative duration between the two implant approaches.
Who should consider this trial
Good fit: Adults eligible for elective repair of a ventral hernia up to 3 × 3 cm on ultrasound or CT who can undergo either mesh-suture or planar mesh repair and attend follow-up visits.
Not a fit: Patients requiring emergency (acute) surgery, pregnant women or those planning future pregnancy, and anyone under 18 are excluded and would not be expected to benefit from this trial.
Why it matters
Potential benefit: If successful, mesh-suture could reduce postoperative wound complications and improve recovery and quality of life after small ventral hernia repair.
How similar studies have performed: Similar device and mesh-design approaches have shown promising but mixed results in small studies, and large randomized evidence comparing mesh-suture to planar mesh is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ventral hernia (maximum size 3 × 3 cm) measured with Ultrasound or CT. * Participants must be eligible for surgical repair using either mesh-suture or planar mesh Exclusion Criteria: * Age \< 18 years. * Acute (emergent) operation. * Pregnancy. * Women with plans for future pregnancies. * Withdrawal of informed consent during admission.
Where this trial is running
Hjørring
- Regionshospital Nordjylland — Hjørring, Denmark (Recruiting)
Study contacts
- Study coordinator: Vitaly A Gameza
- Email: vitgam@rn.dk
- Phone: 045 97640520
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.