Ventralex Vs Stratafix for Primary Ventral Hernias
- Conditions
- Ventral Hernia
- Interventions
- Device: VentralexOther: Stratafix
- Registration Number
- NCT04356976
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Defect 1-4 cm
- Primary ventral hernia in the midline
- BMI<35
- Defect >4cm
- BMI>35
- Recurrent hernia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ventralex Ventralex Repair with Ventralex hernia patch in sublay position Stratafix Stratafix Repair with Stratafix suture
- Primary Outcome Measures
Name Time Method Hernia recurrence One year Recurrence diagnosed at clinical and/or radiologic examination
- Secondary Outcome Measures
Name Time Method Rate of intra-and postoperative complications 30 days Complications occurring intraoperatively or in the postoperative period
Rate of seroma development one year Seroma confirmed at follow-up examination
Persisting pain One year 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
Mean number of days postoperative sick leave 30 days Postoperative sick leave
Trial Locations
- Locations (1)
Karlskoga Hospital
🇸🇪Karlskoga, Sweden