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The Scandcleft project

Randomised control trial of primary surgery for cleft lip and palate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29932826
Enrollment
450
Registered
2016-03-02
Start date
1997-09-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete unilateral cleft lip and palate Genetic Diseases

Interventions

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

Sponsors

University of Manchester
Lead Sponsor
Oslo University Hospital Rikshospitalet
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Non-caucasian 2. Wide Simonart band 3. Prevailing local language not spoken at home

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Denmark, England, Finland, Norway, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026