Abdominal Wall Hernia, Epigastric Hernia Repair, Umbilical Hernia Repair
Conditions
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.
Interventions
DEVICEmesh suture
mesh suture
DEVICEplanar mesh
planar mesh
Sponsors
Regionshospital Nordjylland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Age \< 18 years. * Acute (emergent) operation. * Pregnancy. * Women with plans for future pregnancies. * Withdrawal of informed consent during admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound | 7-13 days after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Hernia-Q Questionnaire | preoperative, postoperative day 10, day 90 | 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. |
| EQ-5D-5L Index Score | preoperative, postoperative day 10, day 90 | 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 |
| EQ-VAS (Visual Analogue Scale) | preoperative, postoperative day 10, day 90 | Patients rate their overall health on a vertical scale from 0 to 100. Interpretation: Higher scores indicate better overall health-related quality of life. |
| DURATION OF SURGERY | The time interval from the first incision to the last stitch is set | Operation time measured in minutes |
Countries
Denmark
Contacts
CONTACTVitaly A Gameza
CONTACTKatrine Holte
STUDY_CHAIRNils Brandenburger
Regionhospital Nordjylland
Outcome results
None listed