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

NCT07476560 | Recruiting DMC FDA Device

• 1 other identifier: VMK-id:2502170
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Abdominal Hernia-Q Questionnaire

  preoperative, postoperative day 10, day 90

• EQ-5D-5L Index Score

  preoperative, postoperative day 10, day 90

• EQ-VAS (Visual Analogue Scale)

  preoperative, postoperative day 10, day 90

• DURATION OF SURGERY

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

Study Arms (2)

mesh suture

EXPERIMENTAL

Device: mesh suture

planar mesh

ACTIVE COMPARATOR

Device: planar mesh

Interventions

mesh suture DEVICE

mesh suture

mesh suture

planar mesh DEVICE

planar mesh

planar mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years.
• Acute (emergent) operation.
• Pregnancy.
• Women with plans for future pregnancies.
• Withdrawal of informed consent during admission.

Sponsors & Collaborators

• Regionshospital Nordjylland: lead

Study Sites (1)

Regionshospital Nordjylland

Hjørring, Denmark

RECRUITING

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nils Brandenburger

  Regionhospital Nordjylland

  STUDY CHAIR

Central Study Contacts

Vitaly A Gameza

CONTACT

045 97640520; vitgam@rn.dk

Katrine Holte

CONTACT

045 97640520; k.holte@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 17, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)