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

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ClinicalTrials.gov Identifier: NCT01334775
Recruitment Status : Terminated (Inclusion speed too slow, no longer relevant and takeover)
First Posted : April 13, 2011
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Orbis Medical Centre
VieCuri Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Open anterior inguinal hernia repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : June 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Difference in early postoperative pain scores [ Time Frame: 0-4 weeks after surgery ]
    Measured with VAS-scores


Secondary Outcome Measures :
  1. Difference in long-term postoperative pain scores [ Time Frame: 4 weeks - 12 months after surgery ]
    Measured with VAS-scores

  2. Number of days to return to normal daily activities [ Time Frame: 0-12 months after surgery ]
  3. Number of days to return to work [ Time Frame: 0-12 months after surgery ]
  4. Differences in use of analgesics [ Time Frame: 0-12 months after surgery ]
    Measured: frequency, dose and type.

  5. Differences in reported Quality of life [ Time Frame: 0-12 months after surgery ]
    Measured with SF-36 questionnaire

  6. Number of patients with complications/adverse events [ Time Frame: 0-12 months after surgery ]
    All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334775


Locations
Netherlands
Academic Medical Centre Amsterdam, dept. of Surgery
Amsterdam, Netherlands, 1105 AZ
Maastricht University Medical Centre, dept. of General Surgery
Maastricht, Netherlands, 6229HX
Orbis Medical Centre
Sittard-Geleen, Netherlands, 6162 BG
VieCuri Medical Centre, dept. of General Surgery
Venlo, Netherlands, 5912 BL
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

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01334775     History of Changes
Other Study ID Numbers: NL36322.068.11
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: April 2011

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