Welcome to the TOPS Website

Welcome to the TOPS (Timing of Primary Surgery for Cleft Palate) Website

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.

This website can be used to access information about the TOPS trial including updates on trial status.

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 Medicines for Children Research Network Clinical Trials Unit at the University of Liverpool (Data Coordinating Centre).

Recruitment status:
558 infants have been recruited to the trial. Recruitment closed in July 2015 and participants are continuing in follow up for the trial.

Country Recruiting Centres Number of Patients Randomised
Brazil University of São Paulo (HRAC Bauru) 165
Denmark Copenhagen Cleft Palate Centre, Copenhagen 19
Århus Speech and Hearing Institute, Århus 26
Norway Oslo University Hospital, Oslo 30
Sweden Helse Bergen HF, Bergen 19
Malmö University Hospital, Malmö 28
Göteborg University, Goteborg 6
Karolinska University Hospital, Stockholm 13
University of Linköping, Linköping 7
Umeå University, Umeå 4
Uppsala University, Uppsala 11
United Kingdom Royal Manchester Children’s Hospital, Manchester 37
Alder Hey Children’s NHS Foundation Trust, Liverpool 24
Royal Belfast Hospital for Sick Children 3
Birmingham Children’s Hospital, Birmingham 23
Royal Victoria Infirmary, Newcastle 41
University Hospitals Bristol NHS Foundation Trust, Bristol 26
Morriston Hospital, Abertawe Bro Morgannwg University Hospital Board, Swansea 6
Leeds General Infirmary, Leeds 25
Royal Hospital for Sick Children, Glasgow 15
Royal Hospital for Sick Children, Edinburgh 12
Salisbury NHS Foundation Trust, Salisbury 9
The Children’s Hospital , John Radcliffe Hospital, Oxford 9
Total 558
Table last updated: 6th June 2019