Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.
Recruitment status was Not yet recruiting
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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. |
- Difference in early postoperative pain scores [ Time Frame: 0-4 weeks after surgery ] [ Designated as safety issue: No ]Measured with VAS-scores
- 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| Contact: Kevin W. van Barneveld, MD | +31 43 3884502 | k.vanbarneveld@maastrichtuniversity.nl |
| 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 | |
| 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 May 19, 2013