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PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results

Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00580177
Acronym
BOOP
Enrollment
472
Registered
2007-12-24
Start date
2000-01-31
Completion date
2005-07-31
Last updated
2007-12-24

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

Conditions

Hernia, Inguinal

Keywords

Inguinal hernia, Randomized controlled trial, Surgery, Complications, Surgical mesh

Brief summary

Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Detailed description

Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair. 472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Interventions

PROCEDURELichtenstein mesh

The different techniques are compared and evaluated according to primary and secondary objectives.

PROCEDUREPerFix Plug®

The different techniques are compared and evaluated according to primary and secondary objectives.

PROCEDUREProlene® Hernia System

The different techniques are compared and evaluated according to primary and secondary objectives.

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age 30-75 years * Men * Primary inguinal hernia * ASA I-III

Exclusion criteria

* \> 75 years * Females * ASA IV * Previous ipsi-lateral hernia surgery * Drug or alchol abuse * Severe illness

Design outcomes

Primary

MeasureTime frame
Time until full functional recovery2 weeks, 3 months, 1 year, 3 years
Operation timeRegistered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesicsDay 1-14, 3 months, 1 year, 3 years after surgery

Secondary

MeasureTime frame
Complication rate2 weeks, 3 months, 1 year, 3 years
Aptness for beeing performed under local anaesthesiaDuring surgery

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026