NCT07476560

Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment

Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Regionshospital Nordjylland · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias. The main questions it aims to answer are: Does mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh? Comparison group: Researchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time. Participants will: Be randomized to receive either planar mesh or mesh-suture during hernia repair surgery. Undergo standardized preoperative assessment, including baseline data and QoL scoring. Attend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.

Conditions

• Abdominal Wall Hernia
• Umbilical Hernia Repair
• Epigastric Hernia Repair

Interventions

Type	Name	Description
DEVICE	mesh suture	mesh suture
DEVICE	planar mesh	planar mesh

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-12-31
• Completion: 2032-12-31
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study