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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| absorbable fixation left side | Active Comparator |
| |
| absorbable fixation right side | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| permanent mesh fixation | Device | Permanent mesh fixation will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with a VAS scale more than 40 | 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). | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| number of invasive interventions (local infiltrations, reoperations) postoperatively | number of invasive interventions (local infiltrations, reoperations) postoperatively, 1 year after surgery | 1 year after surgery |
| number of patients taking analgetics using MCGill painscore |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virga Jesseziekenhuis | Hasselt | Limburg | 3500 | Belgium | ||
| Imelda Ziekenhuis |
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| Label | URL |
|---|---|
| website University Hospital Ghent | View source |
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| absorbable mesh fixation | Device | Absorbable mesh fixation will be used. |
|
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. |
| 1 year post-surgery |
| perioperative morbidity rate | perioperative morbidity rate, 1 year after surgery | 1 year after surgery |
| quality of life by using EQ5D score | 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. | 1 year post-surgery |
| recurrence rate | recurrence rate, 1 year post-surgery | 1 year post-surgery |
| Bonheiden |
| Belgium |
| CHU Charleroi | Charleroi | Belgium |
| St-Vincentius Ziekenhuis | Deinze | Belgium |
| AZ Sint-Dymphna | Geel | Belgium |
| University Hospital Ghent | Ghent | Belgium |
| Ziekenhuis Maas en Kempen | Maaseik | Belgium |
| AZ Sint-Maarten | Mechelen | Belgium |
| Heilig Hart Ziekenhuis | Mol | Belgium |
| UCL Mont-Godinne | Namur | Belgium |
| H. Serruys Ziekenhuis | Ostend | Belgium |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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