Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mesh suture, planar mesh.
- Who it may be relevant to
- Registry conditions: Abdominal Wall Hernia, Umbilical Hernia Repair, Epigastric Hernia Repair. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
Overview
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.
Interventions
- Device mesh suture
mesh suture - Device planar mesh
planar mesh
Primary outcome measures
- Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound [Time frame: 7-13 days after operation]
Secondary outcome measures (4)
- Abdominal Hernia-Q Questionnaire [Time frame: preoperative, postoperative day 10, day 90]
- EQ-5D-5L Index Score [Time frame: preoperative, postoperative day 10, day 90]
- EQ-VAS (Visual Analogue Scale) [Time frame: preoperative, postoperative day 10, day 90]
- DURATION OF SURGERY [Time frame: The time interval from the first incision to the last stitch is set]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Regionshospital Nordjylland — Hjørring
Publications
- Gameza V, Brandenburger N, Leutscher P, Holte K. Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia repair - a randomized, blinded multicenter study. Hernia. 2026 Jul 31;30(1):310. doi: 10.1007/s10029-026-03815-3. PMID 42536214
Identifiers
NCT: NCT07476560 · VMK-id:2502170 · VMK-id:2502170