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

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Lichtenstein operation with a heavy-weight mesh
Lichtenstein operation with a light-weight mesh
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgical and Perioperativ Sciences, Umeå University Hospital
  • Östersund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Heavy-weight

Light-weight

Arm Description

Lichtenstein operation performed with a heavy-weight mesh.

Lichtenstein operation performed with a light-weight mesh.

Outcomes

Primary Outcome Measures

Health-related Quality of Life
Pain

Secondary Outcome Measures

Postoperative complications
Recurrences
Health-care costs
Sick leave

Full Information

First Posted
March 23, 2007
Last Updated
May 31, 2016
Sponsor
Umeå University
Collaborators
Norrlandstingens Regionförbund, Jämtland County Council, Sweden, Västerbotten County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT00451893
Brief Title
The Significance of the Mesh Thickness in the Operation of Inguinal Hernia
Acronym
LJUNO
Official Title
An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Norrlandstingens Regionförbund, Jämtland County Council, Sweden, Västerbotten County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia, polypropylene mesh, heavy-weight mesh, light-weight mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heavy-weight
Arm Type
Active Comparator
Arm Description
Lichtenstein operation performed with a heavy-weight mesh.
Arm Title
Light-weight
Arm Type
Active Comparator
Arm Description
Lichtenstein operation performed with a light-weight mesh.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein operation with a heavy-weight mesh
Intervention Description
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein operation with a light-weight mesh
Intervention Description
Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2
Primary Outcome Measure Information:
Title
Health-related Quality of Life
Time Frame
Two, seven and eleven postoperative days. Four months and one year after the operation.
Title
Pain
Time Frame
Two, seven and eleven postoperative days. Four months and one year after the operation.
Secondary Outcome Measure Information:
Title
Postoperative complications
Time Frame
Four months and one year after the operation.
Title
Recurrences
Time Frame
Four months and one year after the operation.
Title
Health-care costs
Time Frame
Four months and one year after the operation.
Title
Sick leave
Time Frame
Four months and one year after the operation.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku M Haapamaki, MD, PhD
Organizational Affiliation
Umeå University, Department of Surgical and Perioperative Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Nilsson, MD, Ph D
Organizational Affiliation
Umeå University, Department of Surgical and Perioperative Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pär Nordin, MD, PhD
Organizational Affiliation
Umeå University, Department of Surgical and Perioperative Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rojda Gumuscu, MD
Organizational Affiliation
Umeå University, Department of Surgical and Perioperative Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Rutegård, MD, PhD
Organizational Affiliation
Umeå University, Department of Surgical and Perioperative Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgical and Perioperativ Sciences, Umeå University Hospital
City
Umeå
ZIP/Postal Code
SE 90185
Country
Sweden
Facility Name
Östersund Hospital
City
Östersund
ZIP/Postal Code
SE 83183
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33711123
Citation
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.
Results Reference
derived
PubMed Identifier
29353339
Citation
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.
Results Reference
derived

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

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