The Scandcleft project
| ISRCTN | ISRCTN29932826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29932826 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/01/2016
- Registration date
- 02/03/2016
- Last edited
- 06/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English Summary
Background and study aims
Approximately one child in 500-600 is born with a cleft of the lip and/or palate. These arise in the womb when the different components of the lips, the upper jaw and the hard and soft palate fail to complete their growth. One-sided (or unilateral) clefts can include a complete gap in the lip, jaw, and palate. Even with modern surgery to close the cleft, affected children often require lengthy treatment into the late teens to optimise facial and dental appearance, speech, and hearing. The initial surgeries performed in the first year or so of life, are critical in determining the long term outcomes and the need for subsequent treatment. However, there is a great deal of uncertainty and controversy concerning the surgical timing and techniques that should be adopted. The purpose of this study is to compare the success of different surgical techniques for closing complete unilateral clefts of the lip and palate.
Who can participate?
Infants attending cleft lip and palate centres in Denmark, Finland, Norway, Sweden, and the UK
What does the study involve?
Participants are randomly allocated to one of four groups. Those in group 1 undergo lip and soft palate closure at 3-4 months of age and hard palate closure at 12 months/ Those in group 2 have similar treatment than those in group 1 – they just have their hard palate repair at 36 months. Those in group 3 undergo lip repair at 3-4 months and hard and soft palate closure at 12 months. Those in group 4 have their lip and hard palate repaired at 3-4 months and soft palate repaired at 12 months. Records for each group of participants is collected, which includes short term results of the surgery, the recovery period, the need for further surgery, longer term speech and language development, dental and jaw development, and nose/lip appearance.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A total of 9 Cleft Lip and Palate/ Craniofacial Centres in Denmark, Finland, Norway, Sweden and the UK.
When is the study starting and how long is it expected to run for?
September 1997 to September 2024
Who is funding the study?
European Commission
Who is the main contact?
Professor Gunvor Semb
gunvor.semb@manchester.ac.uk
Contact information
Scientific
The University of Manchester
School of Dentistry
NEW ADDRESS: JR Moore Building, Oxford Road
Manchester M13 9PL
Tel. +44- (0)161-2756792
Manchester
M13 9PL
United Kingdom
| Phone | +44- (0)161-2756809 |
|---|---|
| gunvor.semb@manchester.ac.uk |
Study information
| Study design | Family of three RCTs |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Randomised control trial of primary surgery for cleft lip and palate |
| Study hypothesis | Null hypothesis that different surgical protocols for closure of complete unilateral cleft lip and palate do not produce different outcomes |
| Ethics approval(s) | 1. Regional Committee for Medical Research Ethics, Norway, Oslo and Bergen (Regional Komite for Medisinsk Forskningsetikk), 29/08/1997, ref: S-971522 2. Research Committee at Karolinska Hospital, Sweden - Stockholm and Linkoping (Forskningskommitten vid Karolinska Sjukhuset), 31/10/1997, ref: 97-372 3. Gothenburg Regional Research Committee at the University of Gothenburg, Sweden (Göteborgs Regionala Forskningskommitten vid Göteborgs Universitet), 21/05/1997, ref: R257-97 4. Science Ethics Committee, Denmark- Copenhagen and Aarhus (Videnskabsetisk Komite), 13/10/1997, ref: 309/97 5. Helsinki University Hospital Ethics Committee ( HYKS Sairaala Eettinen Toimikunta), 04/09/1997 6. Local Research Ethics Committee, UK - Manchester, Salford & Trafford, June 1999, ref: 99/197 7. Queen’s University of Belfast Ethics Committee, 08/06/1999, ref: 79/99 |
| Condition | Complete unilateral cleft lip and palate |
| Intervention | One surgical protocol was defined to serve as a common method in each trial against which the established local protocols were compared. The common surgical protocol was lip and soft palate closure at 3-4 months and hard palate closure at 12 months. Trial 1: compared this with only a variation in timing: hard palate repair at 36 months Trial 2: compared this with lip repair at 3-4 months followed by hard and soft palate closure at 12 months Trial 3: compared this with lip and hard palate repair at 3-4 months and soft palate repair at 12 months The primary outcomes at age 5 were speech and dentofacial development, with a series of perioperative and longer term secondary outcomes. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Speech and language at age 5 years, via blinded panel assessments using standardised audio/video recordings with regard to consonant proficiency and ratings of velopharyngeal competency and hypernasality 2. Dentofacial development at 5 years, via blinded panel ratings of dentofacial relationship represented by articulated plaster casts of the dentition using the Five Year Yardstick and Huddart-Bodenham Index |
| Secondary outcome measures | 1. Perioperative complications recorded by medical and nursing staff 2. Operation and hospitalisation time 3. Postoperative recovery and feeding recorded by medical and nursing staff 4. Speech at 12 and 18 months and 3 years 5. Symptomatic fistulae 6. Hearing 7. Burden of care 8. Parent satisfaction at age 5 years |
| Overall study start date | 01/09/1997 |
| Overall study end date | 01/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 450 |
| Total final enrolment | 429 |
| Participant inclusion criteria | Caucasian patients born with non-syndromic unilateral complete cleft lip and palate. Patients with a soft tissue bridge (Simonart`s band) could be included as long as the width of the soft tissue bridge was not more than 5mm. The prevailing language of the country where recruited had to be spoken at home. |
| Participant exclusion criteria | 1. Non-caucasian 2. Wide Simonart band 3. Prevailing local language not spoken at home |
| Recruitment start date | 01/09/1997 |
| Recruitment end date | 11/11/2006 |
Locations
Countries of recruitment
- Denmark
- England
- Finland
- Norway
- Sweden
- United Kingdom
Study participating centres
2100
Denmark
00029 HUS
Finland
SE 405 30
Sweden
S-581 85
Sweden
S-171 76
Sweden
NO-0424
Norway
N-5009
Norway
M13 9WL
United Kingdom
BT 12 6BE
United Kingdom
Sponsor information
University/education
Oxford Rd
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 6792 |
|---|---|
| Philip.Eyres@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Hospital/treatment centre
Sognsvannsveien 20
0372 Oslo
Oslo
0372 Oslo
Norway
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 29/02/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Ten manuscripts regarding age 5 outcomes and parent satisfaction will be submitted for journal publication in February 2016 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Other publications | analysis of baseline morphology | 24/12/2020 | 29/12/2020 | Yes | No |
| Results article | comparison of dental arch relationships and dental indices at 5, 8, and 10 years | 03/09/2021 | 06/09/2021 | Yes | No |
Editorial Notes
06/09/2021: Publication reference added.
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
31/01/2019: Publication references added.
