Results of Randomized Controlled Trial of Soft Palate First versus Hard Palate First Repair in Unilateral Complete Cleft Lip and Palate

Abstract

Objective

To compare the outcomes for primary repair of unilateral cleft lip and palate, operating on the soft palate first versus the hard palate first.

Design

Randomized controlled trial.

Setting

The Regional Cleft Service of West Nepal.

Patients

Forty-seven consecutive patients with nonsyndromic unilateral cleft lip and palate, of whom 37 were assessed 4 to 6 years after completing primary surgical repair.

Interventions

Primary repair of unilateral cleft lip and palate by two differing sequences: (1) soft palate repair, with hard palate and lip repair 3 months later; and (2) lip and hard palate repair, followed by the soft palate repair 3 months later.

Main Outcome Measures

Analysis of dental study models, weight gain, and speech recordings.

Results

Four to 7 years after completing the cleft closure, there was no significant difference in facial growth between the two types of repair sequencing. Completing posterior repair first had no effect on anterior alveolar gap width. It narrowed the hard palate gap by reducing the intercanine distance. Anterior repair dramatically closed the anterior alveolar gap, and narrowed the intercanine distance. Comparing anterior alveolar gap width with age at first presentation demonstrated that there was no spontaneous narrowing of the cleft in older children. Completing posterior closure first had a weight gain advantage over anterior closure first. Improved oropharyngeal closure, and thus swallowing, is the likely explanation.

Conclusion

Changing the sequencing of cleft closure has no demonstrable difference in facial growth at 4 to 7 years after completion of the primary surgery.