Incisional Hernia Repair
Conditions
Keywords
Large Pore Size Propylene Mesh, Incisional Hernia, Randomized Controlled Double-blind Study
Brief summary
Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time.
Interventions
DEVICEMesh Implantation
An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.
Sponsors
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female or male patients \>=18 years * Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation * Patients wiht vertical aponeurotic incisions only * Incisional hernia with hernia size \>= 3 cm * Patient is capable to understand and to follow the instructions * written informed consent * no mesh implantation at the same site during a previous operation * immune competence of patient
Exclusion criteria
* Simultanous participation in an investigational drug or medical device study * Patients \< 18 years old * Incisional Hernia withe a hernia size \< 3 cm * Repair of an acute incarcerated hernia * Previous mesh repair at the same site * Patient with other than vertical aponeurotic incisions * Enterotomy to be performed during hernia repair at Surgery * Patient is on anti-coagulations-therapy * Patient is known or assessed to be non-compliant * Additional surgical treatment at the same time (e.g. cholecystectomy) * Immune incompetence of patient (e.g. chemotherapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function score of the SF-36 questionnaire | 21 days after insertion |
Secondary
| Measure | Time frame |
|---|---|
| physical function score from the SF-36 questionnaire | 6 months postoperatively |
| patient's daily activity | 6 months postoperatively |
| patient's pain | 6 months postoperatively |
| wound assessment | 6 months postoperatively |
Countries
Germany
Outcome results
None listed