Back to resultsComparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair (Optilene)
Primary Purpose
Incisional Hernia Repair
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mesh Implantation
Mesh Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia Repair focused on measuring Large Pore Size Propylene Mesh, Incisional Hernia, Randomized Controlled Double-blind Study
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)
Sites / Locations
- Universitaetsklinikum Heidelberg
- Krankenhaus Salem
- Universitaetsklinikum Mannheim
- Klinikum Aschaffenburg
- Andreas Kuthe
- Albert-Schweitzer Krankenhaus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Optilene® Mesh Elastic
Ultrapro® Mesh
Outcomes
Primary Outcome Measures
Physical function score of the SF-36 questionnaire
Secondary Outcome Measures
physical function score from the SF-36 questionnaire
patient's daily activity
patient's pain
wound assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646334
Brief Title
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Acronym
Optilene
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia Repair
Keywords
Large Pore Size Propylene Mesh, Incisional Hernia, Randomized Controlled Double-blind Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Optilene® Mesh Elastic
Arm Title
B
Arm Type
Active Comparator
Arm Description
Ultrapro® Mesh
Intervention Type
Device
Intervention Name(s)
Mesh Implantation
Other Intervention Name(s)
Optilene® Mesh Elastic
Intervention Description
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
Intervention Name(s)
Mesh Implantation
Other Intervention Name(s)
Ultrapro® Mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical function score of the SF-36 questionnaire
Time Frame
21 days after insertion
Secondary Outcome Measure Information:
Title
physical function score from the SF-36 questionnaire
Time Frame
6 months postoperatively
Title
patient's daily activity
Time Frame
6 months postoperatively
Title
patient's pain
Time Frame
6 months postoperatively
Title
wound assessment
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kuthe, Dr.
Organizational Affiliation
DRK Krankenhaus Clementinenhaus, Hannover
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rainer Engemann, Prof. Dr.
Organizational Affiliation
Klinikum Aschaffenburg, Chirurgische Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Kuhlgatz, Dr.
Organizational Affiliation
Albert-Schweitzer-Krankenhaus, Klinik fuer Allgemein- und Viszeralchirurgie, Zentrum fuer Minimalinvasive Chirurgie, Northeim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Kienle, Prof. Dr.
Organizational Affiliation
Universitaetsklinikum Mannheim, Chirurgische Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Buechler, Prof.Dr.Dr.
Organizational Affiliation
Universitaetsklinikum Heidelberg, Abt. fuer Allgemein-, Viszeral-, Unfallchirurgie und Poliklinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moritz von Frankenberg, Dr.
Organizational Affiliation
Krankenhaus Salem, Chirurgische Abteilung, Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Krankenhaus Salem
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Universitaetsklinikum Mannheim
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum Aschaffenburg
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Andreas Kuthe
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30161
Country
Germany
Facility Name
Albert-Schweitzer Krankenhaus
City
Northeim
State/Province
Niedersachsen
ZIP/Postal Code
37154
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
11972542
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.
Results Reference
background
Citation
Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)
Results Reference
background
PubMed Identifier
8681695
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.
Results Reference
background
PubMed Identifier
9082105
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.
Results Reference
background
Citation
Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103
Results Reference
background
PubMed Identifier
8934114
Citation
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.
Results Reference
background
PubMed Identifier
11922736
Citation
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.
Results Reference
background
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
Results Reference
background
Citation
Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45
Results Reference
background
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
Results Reference
background
Citation
Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267
Results Reference
background
PubMed Identifier
20624273
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.
Results Reference
background
PubMed Identifier
23053458
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.
Results Reference
result
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Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
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