Incisional Hernia of Midline of Abdomen
Conditions
Brief summary
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
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.
Intervention model description
Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | One year | Rate of hernia recurrences diagnosed at clinical and/or radiologic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate ofntra- and postoperative complications | 30 days | Rate of complications occurring during or after the repair |
| Rate of seroma | one year | Postoperative seroma |
| Persisting postoperative pain | One year | Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire |
| Sick leave | 30 days | Mean number of postoperative days sick leave |
Countries
Sweden
Contacts
Primary ContactGabriel Sandblom, MD, PhD
Backup ContactAsmatullah Katawazai, MD
Outcome results
None listed