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A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventralex | Experimental | Repair with Ventralex patch in sublay position |
|
| Progrip | Active Comparator | Repair with Progrip in Onlay position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventralex | Device | Repair of the hernia by a Ventralex patch in sublay position |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Rate of hernia recurrences diagnosed at clinical and/or radiologic examination | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate ofntra- and postoperative complications | Rate of complications occurring during or after the repair | 30 days |
| Rate of seroma | Postoperative seroma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Sandblom, MD, PhD | Contact | +4686162362 | gabriel.sandblom@ki.se | |
| Asmatullah Katawazai, MD | Contact | +46586660 00 | asmatullah.katawazai@regionorebrolan.se |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Sandblom, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karlskoga Hospital | Not yet recruiting | Karlskoga | Sweden |
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Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
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The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.
| Progrip |
| Device |
Repair of the hernia by a Progrip mesh in onlay position |
|
| one year |
| Persisting postoperative pain | Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire | One year |
| Sick leave | Mean number of postoperative days sick leave | 30 days |
| Karlskoga Hospital | Recruiting | Karlskoga | Sweden |
|