RESUMEN
BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. METHOD: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. RESULTS: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series. TRIAL REGISTRATION: ISRCTN29932826.
Asunto(s)
Labio Leporino/cirugía , Fisura del Paladar/cirugía , Procedimientos de Cirugía Plástica/métodos , Calidad de Vida , Distribución de Chi-Cuadrado , Preescolar , Labio Leporino/diagnóstico , Labio Leporino/psicología , Fisura del Paladar/diagnóstico , Fisura del Paladar/psicología , Manejo de la Enfermedad , Estética , Femenino , Estudios de Seguimiento , Planificación en Salud , Humanos , Lactante , Masculino , Variaciones Dependientes del Observador , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/fisiopatología , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Postoperative behavioral disorders are common in children, but the occurrence in infants is not yet clear. In the present study we focus on postoperative sleep disturbances, which we hypothesized would be more common after sevoflurane anesthesia than propofol-remifentanil anesthesia. METHODS: In total, 39 infants 4-6-mo-old were prospectively enrolled and randomized to receive either a combination of propofol and remifentanil (n = 17) or sevoflurane and fentanyl anesthesia (n = 22) for surgical repair of cleft lip-gum-palate. Postoperative observations were blinded. The parents kept a sleep diary for 2 wk before admission and 2 wk after returning home. The diary included information about how many times the infant awoke during the night and was difficult to comfort and the longest duration of continuous sleep during the night. RESULTS: Longest continuous sleep was significantly longer in the sevoflurane group (median 7.2 h) compared with the propofol-remifentanil group (median 5.1 h, P < 0.05). No other significant difference was found between groups. Sleep pattern was impaired after surgery in both groups compared with that before surgery (P < 0.01), but it was considered by the parents to be back to normal after a median of 10 days, with no significant difference between groups. CONCLUSION: Postoperative sleep disturbances occur in infants after both propofol-remifentanil and sevoflurane anesthesia. Sevoflurane seems to be associated with less impairment of postoperative sleep than propofol-remifentanil in the first weeks after repair of cleft lip and palate in infants.
