The Significance of the Mesh Thickness in the Operation of Inguinal Hernia (LJUNO)

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Lichtenstein operation with a heavy-weight mesh; Procedure: Lichtenstein operation with 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 Type: Interventional
• Enrollment (Actual): 412
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, SE 90185
    • Department of Surgical and Perioperativ Sciences, Umeå University Hospital
  • Östersund, Sweden, SE 83183
    • Östersund hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heavy-weight; Lichtenstein operation performed with a heavy-weight mesh.	Procedure: Lichtenstein operation with a heavy-weight mesh; Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Active Comparator: Light-weight; Lichtenstein operation performed with a light-weight mesh.	Procedure: Lichtenstein operation with a light-weight mesh; Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain measured with pain assessment scale	McCarthy Visual analog scale (0-150 mm) for postoperative pain. Higher value indicates more pain.	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.	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.	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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Four months after the operation
Postoperative complications	Description and frequency of postoperative complications	Within one year after the operation.
Recurrences	Recurrences of inguinal hernia	Within one year after the operation.
Health-care costs	Total health-care costs	Within one year after the operation.
Sick leave	Post operative sick leave	Within one year after the operation.

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Jämtland County Council, Sweden; Norrlandstingens Regionförbund; Västerbotten County Council, Sweden
• Investigators: Principal Investigator: Markku M Haapamaki, MD, PhD, Umeå University, Department of Surgical and Perioperative Sciences; Study Director: Erik Nilsson, MD, Ph D, Umeå University, Department of Surgical and Perioperative Sciences; Principal Investigator: Pär Nordin, MD, PhD, Umeå University, Department of Surgical and Perioperative Sciences; Principal Investigator: Martin Rutegård, MD, PhD, Umeå University, Department of Surgical and Perioperative Sciences

Publications and helpful links

General Publications

• Rutegard 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: March 23, 2007
• First Submitted That Met QC Criteria: March 23, 2007
• First Posted (Estimated): March 26, 2007

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Inguinal hernia; polypropylene mesh; heavy-weight mesh; light-weight mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal
• Other Study ID Numbers: LJUNO 05-109M