Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegionshospital Nordjylland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years.
Acute (emergent) operation.
Pregnancy.
Women with plans for future pregnancies.
Trial design
Design model
Parallel
Treatments tested in this trial
mesh suture
Devicemesh suture
planar mesh
Deviceplanar mesh
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: mesh sutureExperimental treatment 1 intervention
Group B: planar meshActive comparator 1 intervention
Trial outcomes
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.
Time frame
7-13 days after operationSecondary outcomes
1
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 902
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 903
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 904
DURATION OF SURGERY
Operation time measured in minutes
Time frame
The time interval from the first incision to the last stitch is setSponsors and contacts
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Source ClinicalTrials.gov