Randomised control trial of primary surgery for cleft lip and palate
Complete unilateral cleft lip and palate
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.
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.
1. Non-caucasian 2. Wide Simonart band 3. Prevailing local language not spoken at home