TOPS Trial

Timing of Primary Surgery for Cleft Palate

TOPS is an international randomised control trial which aims to investigate the impact of the timing of surgery for cleft palate repair on speech development.

TOPS Trial Logo

What is the TOPS trial?

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.

Current News

TOPS database is now LOCKED. That means we have collected all TOPS data from all TOPS patients and we can now begin statistical analyses to answer our trial question. If you are a researcher working on TOPS, the DCC will be in touch about site closure.

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 roof of the mouth which is most affected by the cleft for normal speech formation , and also because the majority of participating surgeons are already familiar with it.

All children are followed up for a period of up to 5 years and 11 months during which they will visit the hospital at the age of one year, 3 years and 5 years. During the visits, photographs of the mouth and or the face, video and audio recordings will be taken and their hearing will be assessed by a member of the research team. Data from these assessments will be examined by health professionals including speech and language therapists involved in the TOPS trial to find out how their speech is developing and to check their hearing, growth and other aspects of their development.

Some of the audio /video recordings taken of your child may also be used as part of the training of your speech therapist. They will be used to develop a training package for all of the speech and language therapists involved in the TOPS trial. We are doing this so that all of the speech therapists in the TOPS trial follow the same method when making their assessments.

Why is the TOPS trial examining whether a child's speech is influenced by when their cleft palate is closed?

There has been a longstanding debate about the best time to operate on an isolated cleft palate to obtain good speech. As speaking is a learned behavior, it has been suggested that early corrective surgery will lead to better speech; however, this question has not been investigated thoroughly. Therefore, TOPS examines if earlier closure with surgery at 6 months leads to better speech outcomes as compared to later closure at 12 months.

Velopharyngeal function is the ability to close the space between the nose and mouth tightly when speaking. If tight closure is not possible with surgery, the speech becomes hypernasal (too much speaking through the nose) and it can be difficult to pronounce specific speech sounds. We know from other studies involving children that they can think even minor speech differences are strange. Additionally, schoolteachers may perceive children with hypernasal speech as less competent academically and socially. Therefore, we know that patients must have good velopharyngeal function in order to develop good speech, so it is an important goal when considering when to have corrective surgery for an isolated cleft palate.

Collaborators

National Institutes of Health Logo
University of Liverpool
LCTC - Liverpool Clinical Trials Centre
University of Manchester

The trial is sponsored by the University of Manchester and funded by the National Institute of Health, National Institute for Dental and Craniofacial Research (NIH-NIDCR). TOPS is coordinated by the University of Manchester (Administrative Centre) and the Liverpool Clinical Trials Centre at the University of Liverpool (Data Coordinating Centre).

© 2021 LCTC, a division of the University of Liverpool