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Comparison of outcome in cLEft palate surgery After different types of surgical Repair techniques

Comparison of outcome in cLEft palate surgery After different types of surgical Repair techniques - CLEAR study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57357
Enrollment
159
Registered
2025-01-17
Start date
2025-06-24
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Cleft palate Cleft palate

Interventions

Straight line palatoplasty Z-palatoplasty Palatoplasty with additional buccal flaps

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: - Children with a cleft lip/alveolus/palate or cleft palate only - Patients with and without genetic disorders or malformations - Written informed consent  by both the parents or legally authorized persons with good understanding/mastery of the Dutch language

Exclusion criteria

Exclusion criteria: - Primary surgery elsewhere  - Primary palatoplasty after the age of 12 months (except for patients with Pierre Robin sequence) - When adopted, presentation at the hospital after the age of 9 months  - Deafness - Dutch language not spoken/offered to the child at home

Design outcomes

Primary

MeasureTime frame
What is the difference in speech outcome after these surgical techniques? - canonical babbling: age 12 months - hypernasalitity: age 3 and 5 years

Secondary

MeasureTime frame
- What is the incidence of palatal dehiscences with these surgical techniques? - What is the incidence of fistulas in the palate with these surgical techniques? - What is the incidence of speech correcting surgeries with these surgical techniques?

Countries

Netherlands

Contacts

Public ContactE.C. Paes

Universitair Medisch Centrum Utrecht

clearstudie@umcutrecht.nl088 755 5555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)