Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Karlskoga Hospital
Karlskoga, Sweden
Hernia recurrence
Recurrence diagnosed at clinical and/or radiologic examination
Time frame: One year
Rate of intra-and postoperative complications
Complications occurring intraoperatively or in the postoperative period
Time frame: 30 days
Rate of seroma development
Seroma confirmed at follow-up examination
Time frame: 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
Time frame: One year
Mean number of days postoperative sick leave
Postoperative sick leave
Time frame: 30 days
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