Ventralex vs Stratafix for Primary Ventral Hernias

Study Overview
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Brief Summary
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Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

Detailed Description
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Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery. Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery. The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

Official Title
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Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral Hernias

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Ventralex
* Other: Stratafix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Defect 1-4 cm Primary ventral hernia in the midline BMI<35 Exclusion Criteria: Defect >4cm BMI>35 Recurrent hernia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventralex<br>Repair with Ventralex hernia patch in sublay position | Device: Ventralex<br>* Repair of hernia using Ventralex patch in sublay position<br>|
| Active Comparator: Stratafix<br>Repair with Stratafix suture | Other: Stratafix<br>* Repair of hernia without mesh. Defect closed with Stratafix suture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Recurrence diagnosed at clinical and/or radiologic examination | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intra-and postoperative complications | Complications occurring intraoperatively or in the postoperative period | 30 days | 
| Rate of seroma development | Seroma confirmed at follow-up examination | one year | 
| Persisting pain | Postoperative pain rated with the Ventral Hernia Pain Questionnaire. Pain rated on a scale from 1 to 7, with higher scores indicating more severe pain | One year | 
| Mean number of days postoperative sick leave | Postoperative sick leave | 30 days |