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Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Orbis Medical Centre
VieCuri Medical Centre
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01334775
First received: April 5, 2011
Last updated: April 12, 2011
Last verified: April 2011

April 5, 2011
April 12, 2011
June 2011
December 2011   (final data collection date for primary outcome measure)
Difference in early postoperative pain scores [ Time Frame: 0-4 weeks after surgery ] [ Designated as safety issue: No ]
Measured with VAS-scores
Same as current
Complete list of historical versions of study NCT01334775 on ClinicalTrials.gov Archive Site
  • Difference in long-term postoperative pain scores [ Time Frame: 4 weeks - 12 months after surgery ] [ Designated as safety issue: No ]
    Measured with VAS-scores
  • Number of days to return to normal daily activities [ Time Frame: 0-12 months after surgery ] [ Designated as safety issue: No ]
  • Number of days to return to work [ Time Frame: 0-12 months after surgery ] [ Designated as safety issue: No ]
  • Differences in use of analgesics [ Time Frame: 0-12 months after surgery ] [ Designated as safety issue: No ]
    Measured: frequency, dose and type.
  • Differences in reported Quality of life [ Time Frame: 0-12 months after surgery ] [ Designated as safety issue: No ]
    Measured with SF-36 questionnaire
  • Number of patients with complications/adverse events [ Time Frame: 0-12 months after surgery ] [ Designated as safety issue: Yes ]
    All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)
Same as current
Not Provided
Not Provided
 
Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.
Comparison of Cousin Biotech® Adhesix™ Versus Conventional Mesh in Open Anterior Inguinal Hernia Repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a year in 10-20% of patients. Although this is of major concern, early postoperative pain also has an important impact on patients and their ability to regain normal work and activities. Since inguinal hernia repair is the most frequently performed operation worldwide, a small reduction in loss of workdays can already have significant impact on financial issues. As for the origin of the pain, it might be the result of local inflammation caused by the mesh material, but also by nerve entrapment due to fixation techniques. The development of a new mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related to fixation techniques used in the open hernia repair procedure according to Lichtenstein. Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions and surgeons familiarized themselves with the application.

The investigators would like to conduct a multicentre randomised controlled clinical trial to compare the difference in early postoperative pain after unilateral primary inguinal hernia repair in males. The procedures will be performed in day surgery. Early postoperative pain is defined as the pain during the first month, with a special interest in the first two weeks. In addition, the investigators want to measure the possible benefit in terms of time to return to work, daily activities, quality of life, operation length, complications and long term postoperative pain.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
Procedure: Open anterior inguinal hernia repair
Placement of a surgical mesh in open anterior inguinal hernia repair.
Other Names:
  • Cousin Biotech Adhesix
  • Cousin Biotech Biomesh P8
  • Experimental: Experimental - Cousin Biotech Adhesix
    Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair
    Intervention: Procedure: Open anterior inguinal hernia repair
  • Active Comparator: Conventional - Cousin Biotech Biomesh P8
    Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair
    Intervention: Procedure: Open anterior inguinal hernia repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • Primary, unilateral inguinal hernia
  • Age ≥18 years
  • Social status: professionally employed
  • ASA-score I-III
  • Signed informed consent
  • Elective surgery

Exclusion Criteria:

  • Female
  • Bilateral and/or recurrent inguinal hernia
  • Femoral or scrotal hernia
  • Vasectomy
  • Social status: unemployed
  • Chronic use of pain medication
  • Symptomatic acute hernia (i.e. bowel obstruction, incarceration, strangulation, peritonitis or perforation of bowel contents)
  • ASA-score IV or above
  • Incapacitated adult or no signed informed consent
  • Patient is unable to speak Dutch
Male
18 Years and older
No
Contact: Kevin W. van Barneveld, MD +31 43 3884502 k.vanbarneveld@maastrichtuniversity.nl
Netherlands
 
NCT01334775
NL36322.068.11
No
N.D. Bouvy, MD, PhD, surgeon, Maastricht University Medical Centre, department of General Surgery
Maastricht University Medical Center
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Orbis Medical Centre
  • VieCuri Medical Centre
Principal Investigator: Nicole D. Bouvy, MD, PhD Maastricht University Medical Centre, dept. of General Surgery
Maastricht University Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP