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NCT Number: NCT00451893

The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.

Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

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Key information

Age range

25 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgical and Perioperativ Sciences, Umeå University Hospital, Umeå, Sweden

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About this study

The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.

In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male, age 25 years or older
  • Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before

Exclusion criteria

  • The patient is not able or do not want to give written informed consent
  • The patient is not suitable for an operation in local anesthesia
  • Anticoagulant medication or a known coagulation disorder

Treatment and study plan

Lichtenstein operation with a heavy-weight mesh

Procedure

Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2

Lichtenstein operation with a light-weight mesh

Procedure

Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Primary outcomes

  1. Postoperative pain measured with pain assessment scale

    Time frame: Four months after the operation.

    McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.

  2. Postoperative pain measured with pain assessment scale

    Time frame: One year after the operation.

    McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.

  3. Health-related Quality of Life measured with EQ-5D index

    Time frame: One year after the operation.

    The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

  4. Postoperative pain measured with pain assessment scale for inguinal pain

    Time frame: 10 years

    Inguinal Pain Questionnaire for assessing impact on daily activities. The short form of Inguinal Pain Questionnaire has 7 grades (1-7). Increasing grade means more pain. Grade 1 represents no pain.

Secondary outcomes

  1. Health related quality of life measured with EQ-5D index

    Time frame: 2 days after the operation

    The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

  2. Health related quality of life measured with EQ-5D index

    Time frame: Seven days after the operation.

    The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

  3. Health related quality of life measured with EQ-5D index

    Time frame: Eleven days after the operation.

    The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

  4. Health related quality of life measured with EQ-5D index

    Time frame: Four months after the operation

    The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.

  5. Postoperative complications

    Time frame: Within one year after the operation.

    Description and frequency of postoperative complications

  6. Recurrences

    Time frame: Within one year after the operation.

    Recurrences of inguinal hernia

  7. Health-care costs

    Time frame: Within one year after the operation.

    Total health-care costs

  8. Sick leave

    Time frame: Within one year after the operation.

    Post operative sick leave

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Jämtland County Council, Sweden
  • Norrlandstingens Regionförbund
  • Västerbotten County Council, Sweden

Registry information

Official study title

An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia

Acronym: LJUNO

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2007
Registry last updated
Apr 22, 2026

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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