Skip to content

Comparison of Cousin Biotech® Adhesix* versus conventional mesh in open anterior inguinal hernia repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

Comparison of Cousin Biotech® Adhesix* versus conventional mesh in open anterior inguinal hernia repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial. - Self-adhering mesh versus conventional mesh in inguinal hernia repair.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38042
Enrollment
150
Registered
2011-12-12
Start date
2012-11-28
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inguinal hernia

Interventions

Surgical inguinal hernia repair, with placement of a surgical mesh.

Sponsors

Maastricht Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male Primary, unilateral inguinal hernia Age >=18 years ASA-score I-III Signed informed consent Elective surgery

Exclusion criteria

Exclusion criteria: Female Bilateral and/or recurrent inguinal hernia Femoral or scrotal hernia Vasectomy 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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is postoperative pain as reported during the first month with a special emphasis on analgesics use and pain experienced in the first two postoperative weeks.

Secondary

MeasureTime frame
Time to return to work Time to return to normal daily activity Time to first pain-free sexual intercourse Quality of Life measurement using General SF-36 Questionaire and disease specific Carolina's comfort Scale. Late postoperative pain Operation length Postoperative complications (e.g. infection, recurrence).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)