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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norrlandstingens Regionförbund
Jämtland County Council, Sweden
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Markku Haapamaki, Umeå University
ClinicalTrials.gov Identifier:
NCT00451893
First received: March 23, 2007
Last updated: May 31, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Inguinal Hernia
Procedure: Lichtenstein operation with a heavy-weight mesh
Procedure: Lichtenstein operation with a light-weight mesh
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation. ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: Four months and one year after the operation. ] [ Designated as safety issue: No ]
  • Recurrences [ Time Frame: Four months and one year after the operation. ] [ Designated as safety issue: No ]
  • Health-care costs [ Time Frame: Four months and one year after the operation. ] [ Designated as safety issue: No ]
  • Sick leave [ Time Frame: Four months and one year after the operation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2006
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451893

Locations
Sweden
Department of Surgical and Perioperativ Sciences, Umeå University Hospital
Umeå, Sweden, SE 90185
Östersund Hospital
Östersund, Sweden, SE 83183
Sponsors and Collaborators
Umeå University
Norrlandstingens Regionförbund
Jämtland County Council, Sweden
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: Rojda Gumuscu, MD Umeå University, Department of Surgical and Perioperative Sciences
Principal Investigator: Martin Rutegård, MD, PhD Umeå University, Department of Surgical and Perioperative Sciences
  More Information

Responsible Party: Markku Haapamaki, Associate professor, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00451893     History of Changes
Other Study ID Numbers: LJUNO 05-109M 
Study First Received: March 23, 2007
Last Updated: May 31, 2016
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Inguinal hernia
polypropylene mesh
heavy-weight mesh
light-weight mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 25, 2016