Inguinal HerniaLJUNONCT00451893
The Significance of the Mesh Thickness in the Operation of Inguinal Hernia
A study testing Lichtenstein operation with a heavy-weight mesh and Lichtenstein operation with a light-weight mesh in people with Inguinal Hernia, run by Umeå University at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein operation with a heavy-weight mesh and Lichtenstein operation with a light-weight mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2006to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age 25 years or older
- Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Östersund Hospital
Östersund, SE 83183
Department of Surgical and Perioperativ Sciences, Umeå University Hospital
Umeå, SE 90185
About this study
Official title: An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh 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.
Read the detailed description
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.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein operation with a heavy-weight mesh, Lichtenstein operation with a light-weight mesh
- Keywords
- Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein operation with a heavy-weight meshProcedure or surgery
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Lichtenstein operation with a light-weight meshProcedure or surgery
Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
| Study group | Role | What they receive |
|---|---|---|
| Heavy-weight | Active comparator | Lichtenstein operation performed with a heavy-weight mesh. Receives: Procedure: Lichtenstein operation with a heavy-weight mesh |
| Light-weight | Active comparator | Lichtenstein operation performed with a light-weight mesh. Receives: Procedure: Lichtenstein operation with a light-weight mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured with pain assessment scale
McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.
Measured: Four months after the operation.
Postoperative pain measured with pain assessment scale
McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.
Measured: One year after the operation.
Health-related Quality of Life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Measured: One year after the operation.
Postoperative pain measured with pain assessment scale for inguinal pain
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.
Measured: 10 years
Secondary outcomes (8)
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Measured: 2 days after the operation
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Measured: Seven days after the operation.
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Measured: Eleven days after the operation.
Health related quality of life measured with EQ-5D index
The EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Measured: Four months after the operation
Postoperative complications
Description and frequency of postoperative complications
Measured: Within one year after the operation.
Recurrences
Recurrences of inguinal hernia
Measured: Within one year after the operation.
Health-care costs
Total health-care costs
Measured: Within one year after the operation.
Sick leave
Post operative sick leave
Measured: Within one year after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Norrlandstingens Regionförbund, Jämtland County Council, Sweden, Västerbotten County Council, Sweden
- Responsible party
- Principal investigator, Markku Haapamaki, Umeå University
- Investigators
- Markku M Haapamaki, MD, PhD, Principal investigator, Umeå University, Department of Surgical and Perioperative SciencesErik Nilsson, MD, Ph D, Study director, Umeå University, Department of Surgical and Perioperative SciencesPär Nordin, MD, PhD, Principal investigator, Umeå University, Department of Surgical and Perioperative SciencesMartin Rutegård, MD, PhD, Principal investigator, Umeå University, Department of Surgical and Perioperative Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451893
- Sponsor's protocol ID
- LJUNO 05-109M
- Acronym
- LJUNO
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2007
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, Haapamaki MM. Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh. Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20.
PubMed 29353339Rutegard M, Lindqvist M, Svensson J, Nordin P, Haapamaki MM. Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh. Br J Surg. 2021 Mar 12;108(2):138-144. doi: 10.1093/bjs/znaa049.
PubMed 33711123
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia
- ClinicalTrials.gov ID
- NCT00451893
- Acronym / sponsor ID
- LJUNO / LJUNO 05-109M
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Norrlandstingens Regionförbund, Jämtland County Council, Sweden, Västerbotten County Council, Sweden
- Study start
- Sep 2006 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 26 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy-weight | Active comparator | Procedure: Lichtenstein operation with a heavy-weight meshLichtenstein operation performed with a heavy-weight mesh. |
| Light-weight | Active comparator | Procedure: Lichtenstein operation with a light-weight meshLichtenstein operation performed with a light-weight mesh. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male, age 25 years or older
- Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lichtenstein operation with a heavy-weight meshBard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2 | Procedure or surgery | Heavy-weight |
| Lichtenstein operation with a light-weight meshJohnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2 | Procedure or surgery | Light-weight |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Health related quality of life measured with EQ-5D index
Time frame: 2 days after the operation
Health related quality of life measured with EQ-5D index
Time frame: Seven days after the operation.
Health related quality of life measured with EQ-5D index
Time frame: Eleven days after the operation.
Health related quality of life measured with EQ-5D index
Time frame: Four months after the operation
Postoperative complications
Time frame: Within one year after the operation.
Recurrences
Time frame: Within one year after the operation.
Health-care costs
Time frame: Within one year after the operation.
Sick leave
Time frame: Within one year after the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 29353339Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, Haapamaki MM. Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh. Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20.
- Derived from this study: PubMed 33711123Rutegard M, Lindqvist M, Svensson J, Nordin P, Haapamaki MM. Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh. Br J Surg. 2021 Mar 12;108(2):138-144. doi: 10.1093/bjs/znaa049.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markku M Haapamaki, MD, PhD principal investigator
Umeå University, Department of Surgical and Perioperative Sciences
Erik Nilsson, MD, Ph D study director
Umeå University, Department of Surgical and Perioperative Sciences
Pär Nordin, MD, PhD principal investigator
Umeå University, Department of Surgical and Perioperative Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein operation with a heavy-weight mesh and Lichtenstein operation with a light-weight mesh in people with Inguinal Hernia, run by Umeå University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain measured with pain assessment scale (time frame: Four months after the operation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.