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Completed

NCT Number: NCT04356976

Ventralex Vs Stratafix for Primary Ventral Hernias

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

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karlskoga Hospital

Karlskoga, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Defect 1-4 cm
  • Primary ventral hernia in the midline
  • BMI<35

Exclusion criteria

  • Defect >4cm
  • BMI>35
  • Recurrent hernia

Treatment and study plan

Ventralex

Device

Repair of hernia using Ventralex patch in sublay position

Stratafix

Other

Repair of hernia without mesh. Defect closed with Stratafix suture.

Primary outcomes

  1. Hernia recurrence

    Time frame: One year

    Recurrence diagnosed at clinical and/or radiologic examination

Secondary outcomes

  1. Rate of intra-and postoperative complications

    Time frame: 30 days

    Complications occurring intraoperatively or in the postoperative period

  2. Rate of seroma development

    Time frame: one year

    Seroma confirmed at follow-up examination

  3. Persisting pain

    Time frame: 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

  4. Mean number of days postoperative sick leave

    Time frame: 30 days

    Postoperative sick leave

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: VPatchPriRCT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2020
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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