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

Background
Many surgical protocols are available for the management of unilateral cleft lip and palate (UCLP). The 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 a common practice in cleft centers, including our hospital. One-stage simultaneous repair of both cleft lip and palate has been adopted in many cleft centers with satisfactory results; the main advantages of this protocol are lower theoretical costs and less use of operative facilities. The aim of this study was to compare the two different surgical protocols in children who were operated on for UCLP.
Patients and methods
A randomized controlled trial was conducted on 32 consecutive patients with unoperated UCLP, who were allocated into two groups: group A, which consisted of 14 patients consecutively treated with one-stage simultaneous closure of the lip and hard and soft palate, and group B, which consisted of 18 patients who underwent cleft lip repair and cleft hard palate repair with a vomer flap on the first sitting, and then, repair of the remaining cleft soft palate was performed in the second sitting. The two study groups were evaluated regarding the duration of surgery, the need of intraoperative blood transfusion, postoperative complications in the form of respiratory distress, soft palate disruption, and palatal fistula occurrence, for at least 6 months following one-stage repair in group A and 6 months after soft palate repair in group B.
Results
Both groups were comparable regarding mean age at first operation (=0.056), sex distribution (=0.821), total duration of surgeries (=0.363), and need for postoperative intubation (=0.568). There was no significant difference in prevalence of postoperative palatal fistula (=1.000) and soft palate disruption (=0.142) between both groups.
Conclusion
Both one-stage and two-stage protocols showed comparable outcomes regarding the prevalence of postoperative palatal fistula and soft palate dehiscence.