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A randomized study comparing Lichtenstein with ProGrip repair for primary inguinal hernias

A randomized study comparing Lichtenstein with ProGrip repair for primary inguinal hernias - LIPRO-trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32577
Enrollment
76
Registered
2008-09-22
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

groin hernia inguinal hernia

Interventions

Open mesh-based inguinal hernia repair as is the standard procedure for primary hernia according to the national guidelines. The Lichtenstein encompasses sutured fixation of the mesh, the progrip me

Sponsors

SOFRADIM PRODUCTION-COVIDIEN
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - male patients - primary, uncomplicated inguinal hernia - collar of defect

Exclusion criteria

Exclusion criteria: - 30 yrs >= age >= 75 years - emergency procedure - inclusion in other trials - bilateral inguinal hernia - recurrence

Design outcomes

Primary

MeasureTime frame
To what extent does a sutureless repair (Parietex* ProGrip*) reduce pain during patient follow up after inguinal hernia repair?

Secondary

MeasureTime frame
Is there a difference of pain inducing social consequences between the two groups? Is there a difference of foreign body sensation between the two groups? Is there a difference of chronic pain between the two groups? Is there a difference in postoperative wound complications and recurrence between the two patient groups? Is there a difference of surgery duration between the two patient groups? Is there a difference of return to daily activities and return to work between the two patient groups?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)