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

May 31, 2016 updated by: Markku Haapamaki, Umeå University

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

Unknown

Conditions

Intervention / Treatment

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 (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame
Health-related Quality of Life
Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation.
Two, seven and eleven postoperative days. Four months and one year after the operation.
Pain
Time Frame: Two, seven and eleven postoperative days. Four months and one year after the operation.
Two, seven and eleven postoperative days. Four months and one year after the operation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: Four months and one year after the operation.
Four months and one year after the operation.
Recurrences
Time Frame: Four months and one year after the operation.
Four months and one year after the operation.
Health-care costs
Time Frame: Four months and one year after the operation.
Four months and one year after the operation.
Sick leave
Time Frame: Four months and one year after the operation.
Four months and one year after the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Jämtland County Council, Sweden
Norrlandstingens Regionförbund
Västerbotten County Council, Sweden

Investigators

  • Principal Investigator: Markku M Haapamäki, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 23, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LJUNO 05-109M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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