Clinical trial NCT00646334: Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Official title: A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia Repair
Keywords: Large Pore Size Propylene Mesh
Incisional Hernia
Randomized Controlled Double-blind Study
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Physical function score of the SF-36 questionnaire
timeFrame: 21 days after insertion
Secondary outcomes:
measure: physical function score from the SF-36 questionnaire
timeFrame: 6 months postoperatively
measure: patient's daily activity
timeFrame: 6 months postoperatively
measure: patient's pain
timeFrame: 6 months postoperatively
measure: wound assessment
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Krankenhaus Salem
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
state: Bayern
city: Hannover
country: Germany
facility: Andreas Kuthe
state: Niedersachsen
city: Northeim
country: Germany
facility: Albert-Schweitzer Krankenhaus
state: Niedersachsen
Study officials:
affiliation: DRK Krankenhaus Clementinenhaus, Hannover
name: Andreas Kuthe, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Aschaffenburg, Chirurgische Klinik
name: Rainer Engemann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim
name: Jens Kuhlgatz, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaetsklinikum Mannheim, Chirurgische Klinik
name: Peter Kienle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik
name: Markus Buechler, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Salem, Chirurgische Abteilung, Heidelberg
name: Moritz von Frankenberg, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)
citation: 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.
citation: 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.
citation: Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103
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citation: 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
citation: Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45
citation: 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
citation: Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267
citation: 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.
citation: 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.