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

Inguinal Hernia Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00451893
• Other study ID #: LJUNO 05-109M
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: March 23, 2007
• Last updated: May 31, 2016
• Start date: December 2006
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Lichtenstein operation with a heavy-weight mesh
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
• Lichtenstein operation with a light-weight mesh
Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Locations

Country	Name	City	State
Sweden	Östersund Hospital	Östersund
Sweden	Department of Surgical and Perioperativ Sciences, Umeå University Hospital	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Jämtland County Council, Sweden, Norrlandstingens Regionförbund, Västerbotten County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life		Two, seven and eleven postoperative days. Four months and one year after the operation.	No
Primary	Pain		Two, seven and eleven postoperative days. Four months and one year after the operation.	No
Secondary	Postoperative complications		Four months and one year after the operation.	No
Secondary	Recurrences		Four months and one year after the operation.	No
Secondary	Health-care costs		Four months and one year after the operation.	No
Secondary	Sick leave		Four months and one year after the operation.	No