NCT00184483

Brief Summary

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
405

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

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

October 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

14.2 years

First QC Date

September 15, 2005

Last Update Submit

September 9, 2020

Conditions

Inguinal Hernia

Keywords

SurgeryLichtensteinProlene Hernia SystemPostoperative painRecurrence

Outcome Measures

Primary Outcomes (1)

  • pain postoperative

    3 years

Secondary Outcomes (1)

  • Recurrences after groin hernia repair

    3 years

Study Arms (2)

Lichtenstein's operation

EXPERIMENTAL

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia

Procedure: Lichtenstein's operation

Prolene Hernia System

ACTIVE COMPARATOR

Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia

Procedure: Prolene Hernia System

Interventions

Lichtenstein's operationPROCEDURE

Lichtenstein's operation to repair primary unilateral inguinal hernia

Lichtenstein's operation
Prolene Hernia SystemPROCEDURE

Prolene Hernia System to repair primary unilateral inguinal hernia

Prolene Hernia System

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary unilateral groin hernia in adult

You may not qualify if:

  • recurrence warfarin treatment bilateral groin hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Hernia, InguinalPain, PostoperativeRecurrence

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and SymptomsDisease Attributes

Study Officials

  • Helge E Myrvold, MD PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

October 1, 2001

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

NO(1)