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

NCT07476560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Abdominal Wall Hernia
  • Umbilical Hernia Repair
  • Epigastric Hernia Repair

Interventions

DEVICE

mesh suture

mesh suture

DEVICE

planar mesh

planar mesh

Sponsors & Collaborators

  • Regionshospital Nordjylland

    lead OTHER_GOV

Principal Investigators

  • Nils Brandenburger · Regionhospital Nordjylland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-12-31
Completion
2032-12-31
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476560 on ClinicalTrials.gov