Ventral Hernia
Conditions
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.
Interventions
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient and the staff responsible for the postoperative care of the patient will be masked for the allocation.
Intervention model description
Randomised controlled trial comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Defect 1-4 cm * Primary ventral hernia in the midline * BMI\<35
Exclusion criteria
* Defect \>4cm * BMI\>35 * Recurrent hernia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | One year | Recurrence diagnosed at clinical and/or radiologic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed