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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Regionshospital Nordjylland
RECRUITING
Hjørring
Contact Information
Primary
Vitaly A Gameza
vitgam@rn.dk
045 97640520
Backup
Katrine Holte
k.holte@rn.dk
045 97640520
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 280
Treatments
Experimental: mesh suture
Active_comparator: planar mesh
Related Therapeutic Areas
Sponsors
Leads: Regionshospital Nordjylland

This content was sourced from clinicaltrials.gov