Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07476560

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

Led by Regionshospital Nordjylland · Updated on 2026-03-17

280

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a clinical trial to compare two types of mesh used in surgery for small ventral hernias in adults. The study aims to find out if mesh-suture reduces wound complications, improves patient-reported quality of life, and affects operation time compared to the standard planar mesh. This randomized, blinded multicenter study is sponsored by Regionshospital Nordjylland and focuses on abdominal wall hernias, including umbilical and epigastric hernia repairs. Participants will be randomly assigned to receive either mesh-suture or planar mesh during their hernia repair surgery. Before surgery, they will undergo standardized assessments including baseline data collection and quality of life questionnaires. After surgery, patients will have a wound inspection and ultrasound between 7 and 13 days post-operation. Quality of life will be evaluated again 90 days after surgery through telephone follow-up. The surgery duration from first incision to last stitch will be recorded, and medical records will be reviewed for readmissions within 90 days. During the study, participants will complete quality of life questionnaires before surgery, around day 10, and 90 days after surgery. The primary outcome measured is surgical site occurrences assessed by clinical examination and ultrasound shortly after surgery. Secondary outcomes include different quality of life scores and the length of the surgical procedure. This study involves close monitoring of wound healing, operation time, and patient well-being throughout the 90-day follow-up period, with the total participation spanning from preoperative assessment to the 90-day postoperative evaluation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ventral hernia with a maximum size of 3 x 3 cm measured by ultrasound or CT scan
  • Eligible for surgical repair using either mesh-suture or planar mesh
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Emergency or acute operation
  • Pregnancy
  • Women planning future pregnancies
  • Withdrawal of informed consent during admission

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo surgical repair of ventral hernia using either mesh suture or planar mesh.

1 surgery visit and follow-up within 7 to 13 days

Post-operative Follow-up

Duration - 90 days

Participants are monitored and assessed after surgery to evaluate surgical site occurrences and recovery using clinical examinations, ultrasound, and questionnaires.

3 visits: postoperative day 10, day 13, and day 90

Trial Site Locations

Total: 1 location

1

Regionshospital Nordjylland

Hjørring, Denmark

Actively Recruiting

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Research Team

V

Vitaly A Gameza

K

Katrine Holte

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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