Patients/Families
The TOPS trial: Basics
The main aim of the TOPS trial is to
find out whether the age at which babies have surgery to
have their cleft palate repaired has an influence on the way
their speech develops. If
surgery at one age produces better speech and fewer
side-effects than surgery at another age, this may change
the recommended time of surgery for all babies born with
cleft palate.
Parents of babies born with isolated
cleft palate (i.e. not affecting the lip), who attended one
of the hospitals taking part in TOPS, were invited to
take part in the trial. Taking part was voluntary and
parents could have chosen for their child to have surgery at the usual time offered by the
Hospital.
What happens if my child is taking part in the trial?
If parents decided to take part in
TOPS, the time that their baby had surgery was determined by
a computer programme to make sure that both groups were equal.
There are two groups: surgery at age 6 months and surgery at
age 12 months.
Although the timing of surgery was
different, the way that the surgery was done is the same for
both groups.
The
Sommerlad technique was chosen as the method of surgery,
because it is a well-established procedure intended to
achieve optimal repair of the muscles responsible for speech
formation, and also because the majority of participating
surgeons are already familiar with it.
All babies are followed up until they
are 5 years old and will have a visit at the age of one
year, 3 years and 5 years, to find out how their speech is
developing and to check their hearing, growth and other
aspects of their development.