Inguinal Hernia Clinical Trial
Official title:
Recurrency After Inguinal Herniorraphy With Bi-layer Mesh
Aim The overall aim with this study is to improve outcome after inguinal hernia repair
(IHR). It is not known today if a re-operation due to recurrence after bi-layer mesh IHR is
more complicated than compared with the golden standard method.
Method This project is a registry study. The National hernia register (Svenskt
bråckregister, SBR) which started in 1992 include data that cover nearly 100% of all the
country's hernia operations.
Patient data are collected from SBR. Patients who at the time of surgery were between 18-75
years of age and operated on due to primary inguinal hernia with any of the two mentioned
techniques between 1992-2012 are eligible
Background Surgical repair for inguinal hernia is the most common surgical procedure in the
world. Since the introduction of repair with mesh reinforcement, relapses have decreased
significantly. Recurrence of inguinal hernia affects only 1-2% after inguinal hernia repair
(IHR) [1] and is no longer considered to be a big problem. One problem is that a large
proportion of patients undergoing surgery develop chronic pain from the surgical area [2-4].
New meshes, with new design and new materials are continuously being introduced, with the
aim of reducing the incidence of chronic pain. One of the most common meshes in use today is
the so-called "double-mesh" (bi-layer mesh) [1, 5]. Several studies have shown that bi-layer
mesh can lead to some gains for the patient initially after surgery, but there is no
scientific evidence available that suggest that bi-layer mesh is superior the traditional
tension-free mesh repair in the long term [6, 7]. Several reports have shown that bi-layer
mesh repair give results as good as the golden standard method, where a single sheet mesh is
used.
The surgical technique differ somewhat with respect to which layer of the abdominal is being
used [8], when using a bi-layer- or a single sheet mesh. With the bi-layer mesh you use the
abdominal layer that is usually used (the pre-peritoneal space) in case of re-operation due
to recurrence after open mesh repair. Re-operation after bi-layer mesh IHR is incompletely
studied and it is unclear if this is a more difficult surgical procedure compared with
re-operation for recurrence after standard IHR.
Aim The overall aim with this study is to improve outcome after IHR. It is not known today
if a re-operation due to recurrence after bi-layer mesh IHR is more complicated than
compared with the golden standard method.
Method This project is a registry study. The National hernia register (Svenskt
bråckregister, SBR) which started in 1992 include data that cover nearly 100% of all the
country's hernia operations.
Patient data are collected from SBR. Patients who at the time of surgery were between 18-75
years of age and operated on due to primary inguinal hernia with any of the two mentioned
techniques between 1992-2012 are eligible.
Statistics Parametric and non-parametric statistical methods for descriptive analysis will
be used for comparison within and between the groups. Students t-test.
Power calculation The primary outcome variable for this registry study is the prevalence of
recurrence after bi-layer mesh IHR. This is incompletely mapped. There is no need of a power
calculation because the material of the registry is very large and any relevant differences
between the groups should easily be detected.
Gain of knowledge The results of the study could show that either method of IHR (eg bi-layer
mesh) is less suitable in surgical repair of inguinal hernia, which could be troublesome for
those patients who had surgery with the method.
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