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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Wall Hernia; Epigastric Hernia Repair; Umbilical Hernia Repair
• Intervention / Treatment: Device: mesh suture; Device: planar mesh

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vitaly A Gameza; Phone Number: 045 97640520; Email: vitgam@rn.dk
• Study Contact Backup: Name: Katrine Holte; Phone Number: 045 97640520; Email: k.holte@rn.dk

Study Locations

• Denmark
  • Hjørring, Denmark
    • Recruiting
    • Regionshospital Nordjylland
    • Contact: Vitaly A Gameza; Phone Number: 045 97640520; Email: vitgam@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mesh suture	Device: mesh suture; mesh suture
Active Comparator: planar mesh	Device: planar mesh; planar mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound	Definition: We will apply the standardized CDC (Centers for Disease Control and Prevention ) and VHWG (Ventral Hernia Working Group) definitions for SSO. Evaluation: Clinical examination. Additionally, an ultrasound examination will be performed.	7-13 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Hernia-Q Questionnaire	Scale description: Disease-specific patient-reported outcome measure for abdominal hernia symptoms and quality of life. Score range: Each domain ranges from 1 to 4, where higher scores indicate better health status and fewer symptoms.	preoperative, postoperative day 10, day 90
EQ-5D-5L Index Score	Scale description: Generic health-related quality-of-life instrument assessing five dimensions of health. Score range: The Index Score ranges from < 0 (worst health state, depending on country value set) to 1 (perfect health) and	preoperative, postoperative day 10, day 90
EQ-VAS (Visual Analogue Scale)	Patients rate their overall health on a vertical scale from 0 to 100. Interpretation: Higher scores indicate better overall health-related quality of life.	preoperative, postoperative day 10, day 90
DURATION OF SURGERY	Operation time measured in minutes	The time interval from the first incision to the last stitch is set

Collaborators and Investigators

• Sponsor: Regionshospital Nordjylland
• Investigators: Study Chair: Nils Brandenburger, Regionhospital Nordjylland

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal
• Other Study ID Numbers: VMK-id:2502170 (Other Identifier: Danish Research Ethics Committees)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ethics commettee requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes