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Ventralex Vs Stratafix for Primary Ventral Hernias

Not Applicable
Completed
Conditions
Ventral Hernia
Interventions
Device: Ventralex
Other: 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
Inclusion Criteria
  • Defect 1-4 cm
  • Primary ventral hernia in the midline
  • BMI<35
Read More
Exclusion Criteria
  • Defect >4cm
  • BMI>35
  • Recurrent hernia
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
VentralexVentralexRepair with Ventralex hernia patch in sublay position
StratafixStratafixRepair with Stratafix suture
Primary Outcome Measures
NameTimeMethod
Hernia recurrenceOne year

Recurrence diagnosed at clinical and/or radiologic examination

Secondary Outcome Measures
NameTimeMethod
Rate of intra-and postoperative complications30 days

Complications occurring intraoperatively or in the postoperative period

Rate of seroma developmentone year

Seroma confirmed at follow-up examination

Persisting painOne 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 leave30 days

Postoperative sick leave

Trial Locations

Locations (1)

Karlskoga Hospital

🇸🇪

Karlskoga, Sweden

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