Effects of early palatoplasty on procedural related blood loss and fistula formation in patients with unilateral complete cleft lip and palate: A randomized controlled trial study

Abstract Background: Different timelines are preferred for repair surgeries in patients with unilateral complete cleft lip and palate (UCLP). The aim of this study was to evaluate the effects of early palatoplasty on procedural related blood loss (anemia) and fistula formation in patients with UCLP. Methods: This randomized controlled trial conducted on patients candidate for UCLP repair. Patients in control group underwent cheiloplasty, closure of nasal floor, caudal septum dislocation repair, and primary rhinoplasty in first surgery at age of 28 days-4 months. In second surgery, patients in control group underwent two flap palatoplasty with vomerian flap and intravelar veloplasty, soft palate repair and also myringotomy at age of 9-12 month. In case group, infants underwent cleft lip and nose repair (like control group), hard palate repair in first surgery and then in second surgery, patients underwent soft palate repair with intravelarveloplasty. Results: Fifteen patients were included in each group. Two patients in primary surgery in the case group and two patients in secondary surgery in the control group were developed to oronasal fistula after palatoplasty (P= 0.432). The mean hemoglobin levels in the case and control groups at the primary surgery were 10.32±0.68 and 10.31±0.49 g/dL, respectively (P= 0.968) and at the secondary surgery were 11.29±0.54 and 11.37±0.40 g/dL, respectively (P= 0.666). Conclusion: There were no perioperative hemorrhagic events and need to blood transfusion in both groups. Early palatoplasty may as safe as conventional technique in patients with UCLP.Trial registration number: IRCT20180802040678N5