Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

NCT ID: NCT00646334

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-09-30

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.

Conditions

Incisional Hernia Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Optilene® Mesh Elastic

Group Type: EXPERIMENTAL

Mesh Implantation

Intervention Type: 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.

B

Ultrapro® Mesh

Group Type: ACTIVE_COMPARATOR

Mesh Implantation

Intervention Type: 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.

Interventions

Mesh 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.

Intervention Type: DEVICE

Mesh Implantation

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.

Intervention Type: DEVICE

Other Intervention Names

Optilene® Mesh Elastic; Ultrapro® Mesh

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Kuthe, Dr.

Role: PRINCIPAL_INVESTIGATOR

DRK Krankenhaus Clementinenhaus, Hannover

Rainer Engemann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Aschaffenburg, Chirurgische Klinik

Jens Kuhlgatz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim

Peter Kienle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Mannheim, Chirurgische Klinik

Markus Buechler, Prof.Dr.Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik

Moritz von Frankenberg, Dr.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Salem, Chirurgische Abteilung, Heidelberg

Locations

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Krankenhaus Salem

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Klinikum Aschaffenburg

Aschaffenburg, Bavaria, Germany

Andreas Kuthe

Hanover, Lower Saxony, Germany

Albert-Schweitzer Krankenhaus

Northeim, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 11972542 (View on PubMed)

Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8681695 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9082105 (View on PubMed)

Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8934114 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11922736 (View on PubMed)

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

Reference Type: BACKGROUND

Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45

Reference Type: 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

Reference Type: BACKGROUND

Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 20624273 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23053458 (View on PubMed)

Other Identifiers

AAG-G-H-0505

Identifier Type: -

Identifier Source: org_study_id