Skip to main content
OpenTrials
Completed

NCT Number: NCT00580177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital

Gothenburg, Vastra Gotalandsregionen, SE-421 22, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lichtenstein mesh

Procedure

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

Other names: Inguinal hernioplasty (surgical repair of inguinal hernia)

PerFix Plug®

Procedure

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

Other names: Inguinal hernioplasty (surgical repair of inguinal hernia)

Prolene® Hernia System

Procedure

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

Other names: Inguinal hernioplasty (surgical repair of inguinal hernia)

Primary outcomes

  1. Time until full functional recovery

    Time frame: 2 weeks, 3 months, 1 year, 3 years

  2. Operation time

    Time frame: Registered after completion of surgery

  3. Pain after operation measured on a VAS-scale and amount of consumed analgesics

    Time frame: Day 1-14, 3 months, 1 year, 3 years after surgery

Secondary outcomes

  1. Complication rate

    Time frame: 2 weeks, 3 months, 1 year, 3 years

  2. Aptness for beeing performed under local anaesthesia

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: BOOP

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Dec 24, 2007
Registry last updated
Dec 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.