The HELI pilot: clinical research to investigate the possibility of fixation of the polypropylene mesh with autologous growth factor fibrin glue in hernia inguinalis surgery.

The HELI pilot: clinical research to investigate the possibility of fixation of the polypropylene mesh with autologous growth factor fibrin glue in hernia inguinalis surgery. - HELI pilot

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30095

Enrollment

Registered

2007-01-04

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

hernia

Interventions

Surgery of the hernia inguinalis following the Lichtenstein procedure, at which AGW is used for fixation of the macroporous polypropyleen mesh.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: primary unilateral hernia inguinalis male at least 18 years of age sufficient knowledge of the Dutch language competent to make their own decisions ASA-1 or ASA-2 informed consent is signed

Exclusion criteria

Exclusion criteria: female male with scrotal hernia age under 18 incompetent of making decisions lack of understanding the Dutch language previous groin surgery ASA-3 or ASA-4

Design outcomes

Primary

Measure	Time frame
Recurrence rate (max 10%)	—

Secondary

Measure	Time frame
Pain score day 1, 14 after surgery Pain score 3 months after surgery	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)