Overview

This trial is active, not recruiting.

Condition inguinal hernia
Treatments lichtenstein operation with a heavy-weight mesh, lichtenstein operation with a light-weight mesh
Phase phase 2/phase 3
Sponsor Umeå University
Collaborator Norrlandstingens Regionförbund
Start date December 2006
End date May 2016
Trial size 400 participants
Trial identifier NCT00451893, LJUNO 05-109M

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Lichtenstein operation performed with a heavy-weight mesh.
lichtenstein operation with a heavy-weight mesh
Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2
(Active Comparator)
Lichtenstein operation performed with a light-weight mesh.
lichtenstein operation with a light-weight mesh
Johnson&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2

Primary Outcomes

Measure
Health-related Quality of Life
time frame: 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.

Secondary Outcomes

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

Eligibility Criteria

Male participants at least 25 years old.

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

Additional Information

Official title An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia
Principal investigator Markku M Haapamaki, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Umeå University.