ABSTRACT
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.
Subject(s)
Cleft Lip/surgery , Cleft Palate/surgery , Plastic Surgery Procedures/methods , Quality of Life , Chi-Square Distribution , Child, Preschool , Cleft Lip/diagnosis , Cleft Lip/psychology , Cleft Palate/diagnosis , Cleft Palate/psychology , Disease Management , Esthetics , Female , Follow-Up Studies , Health Planning , Humans , Infant , Male , Observer Variation , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Randomized Controlled Trials as Topic , Risk Assessment , Treatment OutcomeABSTRACT
BACKGROUND: Cleft lip and palate is one of the most common congenital anomalies requiring surgical treatment in children, normally commenced in the first year of life. Following the initiation of a group of multicentre surgical trials of primary surgery, variations in postoperative recovery and management became apparent. An agreement was made for a nurse-led survey in eight surgical centres to document postoperative care and recovery. MATERIALS AND METHODS: A postoperative recovery clinical report form was developed to capture relevant data for the children participating in the four arms of the trials. This included the age and weight at admission, the postoperative recovery setting, pain management, postoperative feeding, post-operative complications, and length of hospital stay. RESULTS: Four hundred and three nursing forms from the first surgical procedure were returned for analysis. Differences in important aspects of care such as postoperative analgesia and postoperative feeding were evident. Postoperative care was influenced by local custom and practice, as little firm clinical evidence exists to guide optimal management. CONCLUSION: Postoperative recovery may play a significant role in the future selection of surgical protocols, and future trials need to consider cross-study site training to familiarise nurses, prior to any changes in surgical methods. TRIAL REGISTRATION: ISRCTN29932826.
Subject(s)
Cleft Lip/surgery , Cleft Palate/surgery , Pain, Postoperative/drug therapy , Plastic Surgery Procedures/methods , Postoperative Care/nursing , Analgesics/therapeutic use , Child , Child, Preschool , Cleft Lip/diagnosis , Cleft Lip/nursing , Cleft Palate/diagnosis , Cleft Palate/nursing , Female , Follow-Up Studies , Humans , Infant , Male , Pain, Postoperative/physiopathology , Postoperative Care/methods , Randomized Controlled Trials as Topic , Plastic Surgery Procedures/adverse effects , Recovery of Function , Scandinavian and Nordic Countries , Treatment Outcome , Wound Healing/physiologyABSTRACT
In Finland about 120 babies are born with cleft lip and palate per year. The largest group is those with isolated cleft palate (60%) and only one fourth have complete cleft lip and palate. The clefts are closed under one year of age. Clefts affect appearance, occlusion and speech and the final outcome can only be assessed at the end of the growth. Centralisation of services and a multidisciplinary team approach has a bigger influence on the final outcome than different treatment protocols, the comparative advantages of which remain unproven. Good documentation is important to assess the level of treatment outcomes.
