Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00451893
Acronym
LJUNO
Enrollment
412
Registered
2007-03-26
Start date
2006-09-01
Completion date
2019-04-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh

Brief 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. 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.

Interventions

PROCEDURELichtenstein operation with a heavy-weight mesh

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

PROCEDURELichtenstein operation with a light-weight mesh

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

Sponsors

Umeå University
Lead SponsorOTHER
Norrlandstingens Regionförbund
CollaboratorOTHER
Jämtland County Council, Sweden
CollaboratorOTHER_GOV
Västerbotten County Council, Sweden
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain measured with pain assessment scaleFour months 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 indexOne 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 pain10 yearsInguinal 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

MeasureTime frameDescription
Health related quality of life measured with EQ-5D index2 days after the operationThe EQ-5D index is a summary measure based on a questionnaire with five domains, each comprising three levels.
Postoperative complicationsWithin one year after the operation.Description and frequency of postoperative complications
RecurrencesWithin one year after the operation.Recurrences of inguinal hernia
Health-care costsWithin one year after the operation.Total health-care costs
Sick leaveWithin one year after the operation.Post operative sick leave

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORMarkku M Haapamaki, MD, PhD

Umeå University, Department of Surgical and Perioperative Sciences

STUDY_DIRECTORErik Nilsson, MD, Ph D

Umeå University, Department of Surgical and Perioperative Sciences

PRINCIPAL_INVESTIGATORPär Nordin, MD, PhD

Umeå University, Department of Surgical and Perioperative Sciences

PRINCIPAL_INVESTIGATORMartin Rutegård, MD, PhD

Umeå University, Department of Surgical and Perioperative Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026