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The International Infant Hydrocephalus Study: concept and rational.
[hydrocephalus with stenosis of the aqueduct of sylvius]
During
the
recent
meetings
of
the
International
Study
Group
on
Neuroendoscopy
and
the
International
Society
for
Pediatric
Neurosurgery
,
the
consensus
view
emerged
that
there
is
a
need
to
assess
the
value
and
efficacy
of
neuroendoscopic
procedures
against
shunting
in
a
scientific
manner
,
to
resolve
long
-lasting
debates
on
the
subject
.
A
prospective
randomized
,
controlled
trial
of
endoscopic
third
ventriculostomy
vs
shunting
in
children
presenting
under
the
age
of
2
years
with
pure
aqueduct
stenosis
is
been
proposed
and
organized
(
the
International
Infant
Hydrocephalus
Study
,
IIHS
)
.
The
participating
surgeons
must
adhere
to
the
philosophy
of
randomization
and
be
suitably
experienced
in
endoscopic
techniques
in
infants
.
The
primary
outcome
of
the
trial
will
be
the
overall
health-related
quality
of
life
of
these
children
at
5
years
of
age
.
Hence
,
the
study
is
focusing
on
the
effect
of
surgery
on
neurodevelopment
,
rather
than
the
less
important
issue
of
shunt
or
stoma
survival
,
that
has
been
debated
extensively
with
no
conclusion
so
far
.
Intention-
to
-treat
analysis
will
be
performed
according
to
the
first
surgery
.
Secondary
outcomes
such
as
complication
and
reoperation
rate
,
total
hospitalization
time
and
cost
,
need
for
repeat
imaging
,
and
others
will
be
analyzed
as
well
.
Pure
aqueduct
stenosis
is
relatively
rare
,
making
recruitment
problematic
,
but
has
been
chosen
to
avoid
other
confounding
factors
that
could
influence
outcome
.
More
than
25
centers
worldwide
have
committed
already
to
patient
recruitment
to
the
study
.
It
is
anticipated
that
recruitment
will
last
for
2
years
,
aiming
for
91
patients
per
arm
.
The
study
has
started
recruiting
patients
already
in
some
countries
.
It
is
hoped
that
the
trial
will
not
only
provide
answers
to
unsettled
debates
on
the
value
of
neuroendoscopy
but
also
create
a
network
of
collaborating
pediatric
neurosurgeons
for
future
initiatives
.
Diseases
Validation
Diseases presenting
"overall health-related quality"
symptom
hydrocephalus with stenosis of the aqueduct of sylvius
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