One-stage simultaneous cleft lip and palate repair versus two-stage repair in children with complete unilateral cleft lip and palate: a randomized study using sealed envelopes

Abstract

any surgical protocols are available for the management of unilateral cleft lip and palate (UCLP). Two-stage protocol (repair of cleft lip at 3-4 months old, followed by repair of cleft palate at the age of 10-18 months) is commonly practiced in cleft centers, including our hospital. One-stage simultaneous repair of both cleft lip and palate has been adopted in many cleft centers with satisfying result, the main advantage of this protocol is the theoretical lower costs and lower operative facilities consumption. The aim of this study was to compare two different surgical protocols in children who were operated on for unilateral cleft lip and palate (UCLP). A randomized controlled trial was held on 32 consecutive patients, at Ain-Shams University Hospitals, with unoperated UCLP, allocated to two groups: group A, which consisted of 14 subjects consecutively treated with one-stage closure of the lip, hard and soft palate; and group B, which consisted of 18 subjects who underwent cleft lip repair and cleft hard palate repair with a vomer flap at first sitting. Then, repair of the remaining cleft soft palate was performed in a second sitting. The 2 study groups were evaluated as regards the duration of surgery, the need of intraoperative blood transfusion, post-operative complications in the form of respiratory distress, soft palate disruption and palatal fistula occurrence. Nasolabial aesthetics was qualitatively assessed by an experienced cleft surgeon (who was not a member of the operating team), 6 months after completing surgical correction of UCLP using 5-grade esthetic index described by Asher-McDade and colleagues in (1991).