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Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optilene LP mesh
Ultrapro mesh
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age ≥18 years
  • unilateral primary reducible inguinal hernia
  • elective operation
  • consent to participate in the study.

Exclusion Criteria:

  • age <18 years
  • irreducible
  • strangulated
  • recurrent hernia
  • inability to understand the questionnaire
  • unwillingness to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    OM group

    UM group

    Arm Description

    Optilene LP mesh

    Ultrapro mesh

    Outcomes

    Primary Outcome Measures

    Chronic Pain
    On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise

    Secondary Outcome Measures

    Chronic Pain
    On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
    Foreign Body Feeling
    The question about foreign body feeling was a yes-or-no question

    Full Information

    First Posted
    July 10, 2015
    Last Updated
    June 8, 2017
    Sponsor
    Tartu University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02500056
    Brief Title
    Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
    Official Title
    Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tartu University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
    Detailed Description
    The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia
    Keywords
    Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    143 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OM group
    Arm Type
    Active Comparator
    Arm Description
    Optilene LP mesh
    Arm Title
    UM group
    Arm Type
    Active Comparator
    Arm Description
    Ultrapro mesh
    Intervention Type
    Device
    Intervention Name(s)
    Optilene LP mesh
    Intervention Description
    Lichtenstein hernioplasty
    Intervention Type
    Device
    Intervention Name(s)
    Ultrapro mesh
    Intervention Description
    Lichtenstein hernioplasty
    Primary Outcome Measure Information:
    Title
    Chronic Pain
    Description
    On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
    Time Frame
    6-month follow-up
    Secondary Outcome Measure Information:
    Title
    Chronic Pain
    Description
    On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
    Time Frame
    3-year follow-up
    Title
    Foreign Body Feeling
    Description
    The question about foreign body feeling was a yes-or-no question
    Time Frame
    6-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years unilateral primary reducible inguinal hernia elective operation consent to participate in the study. Exclusion Criteria: age <18 years irreducible strangulated recurrent hernia inability to understand the questionnaire unwillingness to participate in the study

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

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