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

NCT00646334 | Completed

• 1 other identifier: AAG-G-H-0505
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

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

Keywords

Large Pore Size Propylene Mesh; Incisional Hernia; Randomized Controlled Double-blind Study

Outcome Measures

Primary Outcomes (1)

• Physical function score of the SF-36 questionnaire

  21 days after insertion

Secondary Outcomes (4)

• 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

Study Arms (2)

A

EXPERIMENTAL

Optilene® Mesh Elastic

Device: Mesh Implantation

B

ACTIVE COMPARATOR

Ultrapro® Mesh

Device: Mesh Implantation

Interventions

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.

Also known as: Optilene® Mesh Elastic

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (6)

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Krankenhaus Salem

Heidelberg, Baden-Wurttemberg, 69121, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Aschaffenburg

Aschaffenburg, Bavaria, 63739, Germany

Location

Andreas Kuthe

Hanover, Lower Saxony, 30161, Germany

Location

Albert-Schweitzer Krankenhaus

Northeim, Lower Saxony, 37154, Germany

Location

Related Publications (13)

• 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.

  PMID: 11972542 BACKGROUND

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

  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.

  PMID: 8681695 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.

  PMID: 9082105 BACKGROUND

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

  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.

  PMID: 8934114 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.

  PMID: 11922736 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

  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.

  PMID: 20624273 BACKGROUND

• 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.

  PMID: 23053458 RESULT

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 28, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (6)