Ventral Hernia
Conditions
Keywords
Ventral hernia
Brief summary
To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.
Interventions
DEVICEpermanent mesh fixation
Permanent mesh fixation will be used.
DEVICEabsorbable mesh fixation
Absorbable mesh fixation will be used.
Sponsors
Medtronic - MITG
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* written informed consent from the adult patient (18 years and older, no maximum age) * primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair
Exclusion criteria
* no written informed consent * hernia defects larger than 10cm diameter in width * 'hostile' abdomen; open abdomen treatment * contraindication to pneumoperitoneum * emergency surgery (incarcerated hernia) * lateral or parastomal hernia sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with a VAS scale more than 40 | 1 year after surgery | The Visual Analogue Scale (VAS) is commonly used to measure the intensity of pain or other subjective experiences. It is a simple and effective tool. The VAS consists of a straight line, usually 10 cm long, with endpoints defining extreme limits such as 'No pain' and 'Worst imaginable pain'. Respondents mark a point on the line that represents their perception of their current state. Scoring: Scale Title: Visual Analogue Scale (VAS) Minimum Value: 0 (indicating no pain or the least possible experience of the measured parameter) Maximum Value: 10 (indicating worst imaginable pain or the most extreme experience of the measured parameter) Higher Scores: Indicate a worse outcome (e.g., more intense pain or greater severity of the measured parameter). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of invasive interventions (local infiltrations, reoperations) postoperatively | 1 year after surgery | number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery |
| number of patients taking analgetics using MCGill painscore | 1 year post-surgery | The McGill Pain Questionnaire (MPQ) measures the quality and intensity of pain through three components: Pain Rating Index (PRI): Derived from 78 pain descriptors in four categories: Sensory (S), Affective (A), Evaluative (E), Miscellaneous (M). Each descriptor has a numerical value. Scale Title: Pain Rating Index (PRI) Range: 0-78 Higher Scores: Indicate greater intensity of pain. Present Pain Intensity (PPI): A single-item scale rating current pain on a 6-point scale. Scale Title: Present Pain Intensity (PPI) Range: 0 (No Pain) to 5 (Excruciating Pain) Higher Scores: Indicate greater intensity of pain. Number of Words Chosen (NWC): Total pain descriptors selected. Scale Title: Number of Words Chosen (NWC) Range: 0-20 Higher Scores: Indicate more complex or severe pain. |
| perioperative morbidity rate | 1 year after surgery | perioperative morbidity rate, 1 year after surgery |
| quality of life by using EQ5D score | 1 year post-surgery | The EQ-5D is a standardized instrument for measuring generic health status, providing a descriptive profile and a single index value. Descriptive System: Comprises five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension has three severity levels: No problems, Some problems, Extreme problems. Responses form a five-digit number describing the health state (e.g., 11223). EQ Visual Analogue Scale (EQ VAS): Records self-rated health on a vertical scale from 0 (Worst health) to 100 (Best health), quantifying the patient's overall health perception. EQ-5D Index Value: Derived from the descriptive system. Scale Title: EQ-5D Index Value Range: Typically -0.594 to 1 Higher Scores: Indicate better health outcomes. |
| recurrence rate | 1 year post-surgery | recurrence rate, 1 year post-surgery |
Countries
Belgium
Outcome results
None listed