NCT00580177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

Enrollment Period

5.5 years

First QC Date

December 21, 2007

Last Update Submit

December 21, 2007

Conditions

Hernia, Inguinal

Keywords

Inguinal herniaRandomized controlled trialSurgeryComplicationsSurgical mesh

Outcome Measures

Primary Outcomes (3)

  • Time until full functional recovery

    2 weeks, 3 months, 1 year, 3 years

  • Operation time

    Registered after completion of surgery

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

    Day 1-14, 3 months, 1 year, 3 years after surgery

Secondary Outcomes (2)

  • Complication rate

    2 weeks, 3 months, 1 year, 3 years

  • Aptness for beeing performed under local anaesthesia

    During surgery

Study Arms (3)

L

ACTIVE COMPARATOR

The Lichtenstein procedure for repair of inguinal hernia (Single On-lay patch)

Procedure: Lichtenstein mesh

P

ACTIVE COMPARATOR

The well-konown PerFixPlug technique for inguinal hernia repair.

Procedure: PerFix Plug®

PHS

ACTIVE COMPARATOR

The well-known Prolene Hernia System method for inguinal hernia repair.

Procedure: Prolene® Hernia System

Interventions

Lichtenstein meshPROCEDURE

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

Also known as: Inguinal hernioplasty (surgical repair of inguinal hernia)
L
PerFix Plug®PROCEDURE

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

Also known as: Inguinal hernioplasty (surgical repair of inguinal hernia)
P
Prolene® Hernia SystemPROCEDURE

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

Also known as: Inguinal hernioplasty (surgical repair of inguinal hernia)
PHS

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gothenburg, Vastra Gotalandsregionen, SE-421 22, Sweden

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jan A Dalenbäck, Ass. Prof.

    Frolunda Specialist Hospital, University of Gothenburg

    PRINCIPAL INVESTIGATOR

  • Jan A Dalenbäck, Ass. Prof.

    Frolunda Specialist Hospital, University of Gothenburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 24, 2007

Study Start

January 1, 2000

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

SE(1)