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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Optilene® Mesh Elastic |
|
| B | Active Comparator | Ultrapro® Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh Implantation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function score of the SF-36 questionnaire | 21 days after insertion |
| Measure | Description | Time Frame |
|---|---|---|
| physical function score from the SF-36 questionnaire | 6 months postoperatively | |
| patient's daily activity | 6 months postoperatively | |
| patient's pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Kuthe, Dr. | DRK Krankenhaus Clementinenhaus, Hannover | Principal Investigator |
| Rainer Engemann, Prof. Dr. | Klinikum Aschaffenburg, Chirurgische Klinik | Principal Investigator |
| Jens Kuhlgatz, Dr. | Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim | Principal Investigator |
| Peter Kienle, Prof. Dr. | Universitaetsklinikum Mannheim, Chirurgische Klinik | Principal Investigator |
| Markus Buechler, Prof.Dr.Dr. | Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik | Principal Investigator |
| Moritz von Frankenberg, Dr. | Krankenhaus Salem, Chirurgische Abteilung, Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany | ||
| Krankenhaus Salem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11972542 | Background | Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. doi: 10.1046/j.1365-2168.2002.02083.x. | |
| Background | Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35) | ||
| 8681695 |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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|
|
| Mesh Implantation | Device | Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips. |
|
|
| 6 months postoperatively |
| wound assessment | 6 months postoperatively |
| Heidelberg |
| Baden-Wurttemberg |
| 69121 |
| Germany |
| Universitaetsklinikum Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Klinikum Aschaffenburg | Aschaffenburg | Bavaria | 63739 | Germany |
| Andreas Kuthe | Hanover | Lower Saxony | 30161 | Germany |
| Albert-Schweitzer Krankenhaus | Northeim | Lower Saxony | 37154 | Germany |
| Background |
| Klinge U, Conze J, Limberg W, Brucker C, Ottinger AP, Schumpelick V. [Pathophysiology of the abdominal wall]. Chirurg. 1996 Mar;67(3):229-33. German. |
| 9082105 | Background | Klinge U, Conze J, Klosterhalfen B, Limberg W, Obolenski B, Ottinger AP, Schumpelick V. [Changes in abdominal wall mechanics after mesh implantation. Experimental changes in mesh stability]. Langenbecks Arch Chir. 1996;381(6):323-32. doi: 10.1007/BF00191312. German. |
| Background | Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103 |
| 8934114 | Background | Beets GL, Go PM, van Mameren H. Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs. Eur J Surg. 1996 Oct;162(10):823-5. |
| 11922736 | Background | Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res. 2002 Apr;103(2):208-14. doi: 10.1006/jsre.2002.6358. |
| Background | Benhidjeb T, Baerlehner E, Anders S. Laparoskopische Narbenhernien Reparation: Muss das Netz fuer die Intraperitoneale Onlay-Mesh-Technik besondere Eigenschaften haben?; Chir. Gastroenterol. 2003; 19(Suppl.2): 16-22 |
| Background | Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45 |
| Background | Rosch R, Junge K, Stumpf M, Klinge U, Schumpelick V, Klosterhalfen B; Welche Anforderungen sollte ein ideales Netz erfuellen?; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 7-11 |
| Background | Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267 |
| 20624273 | Background | Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair. BMC Surg. 2010 Jul 12;10:21. doi: 10.1186/1471-2482-10-21. |
| 23053458 | Result | Rickert A, Kienle P, Kuthe A, Baumann P, Engemann R, Kuhlgatz J, von Frankenberg M, Knaebel HP, Buchler MW. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg. 2012 Dec;397(8):1225-34. doi: 10.1007/s00423-012-1009-6. Epub 2012 Oct 3. |
| D010335 | Pathologic Processes |