“Does age during cleft palate closure have an impact on postoperative complications? A randomized trial”

BACKGROUND: The optimal timing of cleft palate closure remains debated, balancing potential benefits for speech and hearing against risks of postoperative complications and long-term effects. Current Dutch guidelines recommend closure before 12 months, but some studies suggest earlier repair at 6-8 months may improve functional outcomes. METHODS: We conducted a randomized cohort study of 82 children with cleft lip and palate or isolated cleft palate, allocated to early (6-8 months) or late (10-12 months) palatal closure. Primary outcomes were intra- and postoperative complications, including bleeding, infection, dehiscence, and oronasal fistula. Secondary outcomes included operative time, hospital stay, and associations between patient characteristics and outcomes. RESULTS: Eighty patients were analyzed (43 early, 37 late). Baseline characteristics were comparable between groups. The mean operative time was shorter in the early group (p = 0.005), while hospital stay was similar. No intraoperative complications or blood transfusions occurred. Postoperative infection was rare (2.3% in the early group vs. 5.4% in the late group). Wound healing problems occurred in 14 patients (32.6%) in the early group and 14 patients (37.8%) in the late group (p = 0.479). Within this category, wound dehiscence was observed in 6 patients (13.9%) in the early group and 4 patients (10.8%) in the late group (p = 0.485). All wounds had spontaneously healed by the 3-month follow-up. During follow-up, fistula formation was observed in 7 patients (16.3%) in the early group and 10 patients (27.0%) in the late group (p = 0.281). Four patients (9.3%) in the early group and three patients (8.1%) in the late group required symptomatic fistula repair before age 3 years (p = 0.350). No significant differences were found between the groups. Subsequently three patients in the early group had fistula surgery combined with VPI surgery at an average age of 56 months and seven patients in the late group at an average of 61 months. Importantly, cleft width was significantly reduced following vomer flap closure (p < 0.001). Moreover, greater initial cleft width independently predicted fistula development (p = 0.048). CONCLUSION: Early palatal closure at 6-8 months is safe and does not increase short-term complications compared to closure at 10-12 months. Operative time was reduced in the early closure group, and a vomer flap effectively narrowed cleft width. As the initial cleft width prior to surgery was a predictor of fistula formation, reducing width may contribute to improved outcomes. Larger, multicenter studies are needed to confirm safety and assess long-term speech, hearing, and maxillary growth outcomes.