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

A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia Repair
• Intervention / Treatment: Device: Mesh Implantation; Device: Mesh Implantation

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinikum Heidelberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69121
      • Krankenhaus Salem
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • Universitaetsklinikum Mannheim
  • Bayern
    • Aschaffenburg, Bayern, Germany, 63739
      • Klinikum Aschaffenburg
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30161
      • Andreas Kuthe
    • Northeim, Niedersachsen, Germany, 37154
      • Albert-Schweitzer Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Optilene® Mesh Elastic	Device: 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.; Other Names: Optilene® Mesh Elastic; 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.; Other Names: Ultrapro® Mesh
Active Comparator: B; Ultrapro® Mesh	Device: 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.; Other Names: Optilene® Mesh Elastic; 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.; Other Names: Ultrapro® Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical function score of the SF-36 questionnaire	21 days after insertion

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)
• 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.
• 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.
• Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103
• 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.
• 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.
• 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
• Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45
• 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
• Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 28, 2008

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Incisional Hernia; Large Pore Size Propylene Mesh; Randomized Controlled Double-blind Study
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: AAG-G-H-0505