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| ID | Type | Description | Link |
|---|---|---|---|
| VMK-id:2502170 | Other Identifier | Danish Research Ethics Committees |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesh suture | Experimental |
| |
| planar mesh | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesh suture | Device | mesh suture |
| |
| planar mesh |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | preoperative, postoperative day 10, day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vitaly A Gameza | Contact | 045 97640520 | vitgam@rn.dk | |
| Katrine Holte | Contact | 045 97640520 | k.holte@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Nils Brandenburger | Regionhospital Nordjylland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regionshospital Nordjylland | Recruiting | Hjørring | Denmark |
Ethics commettee requirements
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2025 | Dec 5, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
planar mesh |
|
| 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 |
| 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. | preoperative, postoperative day 10, day 90 |
| DURATION OF SURGERY | Operation time measured in minutes | The time interval from the first incision to the last stitch is set |