Is a one stage or two stage cleft palate repair more beneficial in children with complete one sided cleft palate defects with respect to speech development and palatal fistula formation?

Effect of one-stage versus two-stage cleft palate repair on speech and fistula formation in children with complete unilateral cleft lip and palate: A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17288141

Enrollment

120

Registered

2017-05-31

Start date

2010-01-01

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Complete unilateral cleft palate Musculoskeletal Diseases Complete unilateral cleft palate

Interventions

Patients with non-syndromic complete unilateral cleft lip and palate with a repaired cleft lip are randomly allocated into one of two groups of 50 each using block randomisation. Grou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: 1. Patients of either gender 2. Patients aged 12-13 months 3. Non-syndromic complete unilateral cleft lip and palate with a previously repaired cleft lip Controls: 1. Patients of either gender 2. Patients aged 6 years 3. No history of cleft lip and/or palate defect

Exclusion criteria

Exclusion criteria: 1. Bilateral cleft lip and palate 2. Isolated cleft palate 3. Patients younger than 12 months and older than 13 months of age 4. Patients with associated syndromic conditions

Design outcomes

Primary

Measure	Time frame
Hypernasality of speech will be measured by nasometry and perceptual outcomes at age 6 years	—

Secondary

Measure	Time frame
Fistula rates will tested clinically using observation and non-invasive palpation at age 3 years.	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026