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NCT Number: NCT07476560

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

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.

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Key information

Conditions

Abdominal Wall Hernia Epigastric Hernia Repair Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Umbilical Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mesh suture

Device

mesh suture

planar mesh

Device

planar mesh

Primary outcomes

  1. Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound

    Time frame: 7-13 days after operation

    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.

Secondary outcomes

  1. Abdominal Hernia-Q Questionnaire

    Time frame: preoperative, postoperative day 10, day 90

    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.

  2. EQ-5D-5L Index Score

    Time frame: preoperative, postoperative day 10, day 90

    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

  3. EQ-VAS (Visual Analogue Scale)

    Time frame: preoperative, postoperative day 10, day 90

    Patients rate their overall health on a vertical scale from 0 to 100.

    Interpretation: Higher scores indicate better overall health-related quality of life.

  4. DURATION OF SURGERY

    Time frame: The time interval from the first incision to the last stitch is set

    Operation time measured in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Katrine Holte

CONTACT

[email protected]

045 97640520

Vitaly A Gameza

CONTACT

[email protected]

045 97640520

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Registry information

Official study title

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

Acronym: MeMa

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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