The Scandcleft project

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. CONDITION: Complete unilateral cleft lip and palate ; Genetic Diseases PRIMARY OUTCOME: 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: 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 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.