An interventional study of mesh suture and planar mesh in Abdominal Wall Hernia, Umbilical Hernia Repair and Epigastric Hernia Repair, sponsored by Regionshospital Nordjylland. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and 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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's planned enrollment of 280 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: mesh suture
Device: planar mesh
mesh suture
planar mesh
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.
Time frame: 7-13 days after operation
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.
Time frame: 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
Time frame: 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.
Time frame: preoperative, postoperative day 10, day 90
DURATION OF SURGERY
Operation time measured in minutes
Time frame: The time interval from the first incision to the last stitch is set
Plan to share: No — Ethics commettee requirements
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Regionshospital Nordjylland