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

NCT00451893 | Completed

• 1 other identifier: LJUNO 05-109M
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

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

  2 days after the operation

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

  Seven days after the operation.

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

  Eleven days after the operation.

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

  Four months after the operation

• Postoperative complications

  Within one year after the operation.

Study Arms (2)

Heavy-weight

ACTIVE COMPARATOR

Lichtenstein operation performed with a heavy-weight mesh.

Procedure: Lichtenstein operation with a heavy-weight mesh

Light-weight

ACTIVE COMPARATOR

Lichtenstein operation performed with a light-weight mesh.

Procedure: Lichtenstein operation with a light-weight mesh

Interventions

Lichtenstein operation with a heavy-weight mesh PROCEDURE

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

Heavy-weight

Lichtenstein operation with a light-weight mesh PROCEDURE

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

Light-weight

Eligibility Criteria

• Age: 25 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Norrlandstingens Regionförbund: collaborator
• Jämtland County Council, Sweden: collaborator
• Västerbotten County Council, Sweden: collaborator

Study Sites (2)

Östersund Hospital

Östersund, SE 83183, Sweden

Location

Department of Surgical and Perioperativ Sciences, Umeå University Hospital

Umeå, SE 90185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 29353339 RESULT

• 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.

  PMID: 33711123 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Markku M Haapamaki, MD, PhD

  Umeå University, Department of Surgical and Perioperative Sciences

  PRINCIPAL INVESTIGATOR

• Erik Nilsson, MD, Ph D

  Umeå University, Department of Surgical and Perioperative Sciences

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Study Record Dates

• First Submitted: March 23, 2007
• First Posted: March 26, 2007
• Study Start: September 1, 2006
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 22, 2026

Record last verified: 2021-09

Locations

SE (2)