The Significance of the Mesh Thickness in the Operation of Inguinal Hernia - Full Text View

Sponsors and Collaborators:	Umeå University County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND) County Council of Jämtland
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00451893

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 II Phase III

MedlinePlus related topics: Hernia Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Expertise-Based Multicentre Randomized Controlled Trial Comparing a Heavy-Weight and a Light-Weight Mesh in the Operation of Inguinal Hernia

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 Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Heavy-weight: Active Comparator	Procedure: Lichtenstein operation with a heavy-weight mesh Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
Light-weight: Active Comparator	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
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

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

Contacts

Contact: Markku M Haapamaki, MD, PhD	+46-907852013	markku.haapamaki@surgery.umu.se
Contact: Anders Sylvan, MD, PhD	+46-907850000	anders.sylvan@vll.se

Locations

Sweden
Department of Surgery, Umeå University Hospital	Recruiting
Umeå, Sweden, SE 90185
Contact: Markku M Haapamaki, MD, PhD +46-907852013 markku.haapamaki@surgery.umu.se
Contact: Anders Sylvan, MD, PhD +46-907850000 anders.sylvan@vll.se
Principal Investigator: Markku M Haapamaki, MD, PhD
Principal Investigator: Georgios Stylianides, MD
Östersund Hospital	Recruiting
Östersund, Sweden, SE 83183
Contact: Pär Nordin, MD, PhD +46-63-153000 par.nordin@jll.se
Principal Investigator: Pär Nordin, MD, PhD

Sponsors and Collaborators

Umeå University

County Councils of Northern Sweden (Norrlandstingens REGIONFÖRBUND)

County Council of Jämtland

Investigators

Study Chair:	Peter Naredi, MD, PhD	Umeå University
Principal Investigator:	Markku M Haapamaki, MD, PhD	Umeå University
Study Director:	Erik Nilsson, MD, Ph D	Umeå University
Principal Investigator:	Pär Nordin, MD, PhD	Östersund Hospital
Principal Investigator:	Georgios Stylianides, MD	Umeå University

More Information

No publications provided

Responsible Party:	County Council of Jämtland ( Pär Nordin, MD, PhD )
Study ID Numbers:	LJUNO 05-109M
Study First Received:	March 23, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00451893 History of Changes
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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Body Weight
Hernia
Hernia, Abdominal
Hernia, Inguinal

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal
Hernia, Inguinal

ClinicalTrials.gov processed this record on May 07, 2009