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Completed

NCT Number: NCT02500056

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

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.

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Key information

Conditions

Inguinal Hernia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Optilene LP mesh

Device

Lichtenstein hernioplasty

ULTRAPRO Mesh

Device

Lichtenstein hernioplasty

Primary outcomes

  1. Chronic Pain

    Time frame: 6-month follow-up

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

Secondary outcomes

  1. Chronic Pain

    Time frame: 3-year follow-up

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

  2. Foreign Body Feeling

    Time frame: 6-month follow-up

    The question about foreign body feeling was a yes-or-no question

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Jul 11, 2017

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.

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