NCT00451893

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

An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: Male
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
PROCEDURE	Lichtenstein operation with a heavy-weight mesh	Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
PROCEDURE	Lichtenstein operation with a light-weight mesh	Johnson\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Timeline

• Start date: 2006-12-01
• Primary completion: 2016-05-01
• Completion: 2016-11-01
• First posted: 2007-03-26
• Last updated: 2016-06-01

Locations

2 sites across 1 country: Sweden