An interventional study of Open anterior inguinal hernia repair in Inguinal Hernia, sponsored by Maastricht University Medical Center. Terminated at 4 sites in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair
Procedure: Open anterior inguinal hernia repair
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.
Also known as: Cousin Biotech Adhesix, Cousin Biotech Biomesh P8
Difference in early postoperative pain scores
Measured with VAS-scores
Time frame: 0-4 weeks after surgery
Difference in long-term postoperative pain scores
Measured with VAS-scores
Time frame: 4 weeks - 12 months after surgery
Number of days to return to normal daily activities
Time frame: 0-12 months after surgery
Number of days to return to work
Time frame: 0-12 months after surgery
Differences in use of analgesics
Measured: frequency, dose and type.
Time frame: 0-12 months after surgery
Differences in reported Quality of life
Measured with SF-36 questionnaire
Time frame: 0-12 months after surgery
Number of patients with complications/adverse events
All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)
Time frame: 0-12 months after surgery
This study is terminated, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center