RCT Ventralex vs Onlay Mesh in Incisional Hernias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ventralex, Progrip.
- Who it may be relevant to
- Registry conditions: Incisional Hernia of Midline of Abdomen. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
Overview
A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias
Detailed description
Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.
Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.
Interventions
- Device Ventralex
Repair of the hernia by a Ventralex patch in sublay position - Device Progrip
Repair of the hernia by a Progrip mesh in onlay position
Primary outcome measures
- Recurrence rate [Time frame: One year]
Secondary outcome measures (4)
- Rate ofntra- and postoperative complications [Time frame: 30 days]
- Rate of seroma [Time frame: one year]
- Persisting postoperative pain [Time frame: One year]
- Sick leave [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Hernia defect 1-4 cm
- Incisional hernia or recurrent hernia after previous primary hernia repair
- BMI <35
- Age 18-100 years
Exclusion criteria
- Defect size>4 cm
- Ongoing pregnancy
- BMI>35
- Primary hernia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Karlskoga Hospital — Karlskoga
- Karlskoga Hospital — Karlskoga
Identifiers
NCT: NCT04358159 · VPatchIncRCT