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
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: Open anterior inguinal hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cousin Biotech® Adhesix™ Versus Conventional Mesh in Open Anterior Inguinal Hernia Repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Difference in early postoperative pain scores [ Time Frame: 0-4 weeks after surgery ] [ Designated as safety issue: No ]
    Measured with VAS-scores


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental - Cousin Biotech Adhesix
Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair
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
Active Comparator: Conventional - Cousin Biotech Biomesh P8
Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334775

Contacts
Contact: Kevin W. van Barneveld, MD +31 43 3884502 k.vanbarneveld@maastrichtuniversity.nl

Locations
Netherlands
Academic Medical Centre Amsterdam, dept. of Surgery Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: Marlies P. Schijven, MD, PhD, MHSc         
Sub-Investigator: Lindsey C. de Nes, MD         
Maastricht University Medical Centre, dept. of General Surgery Not yet recruiting
Maastricht, Netherlands, 6229HX
Principal Investigator: Nicole D. Bouvy, MD, PhD         
Sub-Investigator: Kevin W. van Barneveld, MD         
Orbis Medical Centre Not yet recruiting
Sittard-Geleen, Netherlands, 6162 BG
Principal Investigator: Jan H. Stoot, MD         
VieCuri Medical Centre, dept. of General Surgery Not yet recruiting
Venlo, Netherlands, 5912 BL
Principal Investigator: Charles L. van Berlo, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Orbis Medical Centre
VieCuri Medical Centre
Investigators
Principal Investigator: Nicole D. Bouvy, MD, PhD Maastricht University Medical Centre, dept. of General Surgery
  More Information

No publications provided

Responsible Party: N.D. Bouvy, MD, PhD, surgeon, Maastricht University Medical Centre, department of General Surgery
ClinicalTrials.gov Identifier: NCT01334775     History of Changes
Other Study ID Numbers: NL36322.068.11
Study First Received: April 5, 2011
Last Updated: April 12, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Inguinal hernia
Postoperative pain
Surgical mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 28, 2014