Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age.
Scandicle单侧唇腭裂初次手术的随机试验: 8 岁时上颌骨生长。
- 作者列表："Küseler A","Mølsted K","Marcusson A","Heliövaara A","Karsten A","Bellardie H","Sæle P","Brinck E","Skaare P","Rizell S","Chalien MN","Mooney J","Eyres P","Shaw W","Semb G
OBJECTIVES:To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project. DESIGN AND SETTING:Prospective, randomized, controlled clinical trial (RCT) involving 10 centres, including non-syndromic Caucasians with unilateral cleft lip and palate (UCLP). In Trial 1, a common surgical method (1a) with soft palate closure at 3-4 months of age and hard palate closure at 12 months of age was tested against similar surgery but with hard palate repair at 36 months (delayed hard palate closure) (1b). In Trial 2, the common method (2a) was tested against simultaneous closure of both hard and soft palate at 1 year (2c). In Trial 3, the common method (3a) was tested against hard palate closure together with lip closure at 3 months of age and soft palate closure at 1 year of age (3d). Participants were randomly allocated by use of a dice. Operator blinding was not possible but all raters of all outcomes were blinded. SUBJECTS AND METHODS:The total number of participating patients at 8 years of age was 429. Lateral cephalograms (n = 408) were analysed. The cephalometric angles SNA and ANB were chosen for assessing maxillary growth for this part of the presentation. RESULTS:Within each trial (Trial 1a/1b, Trial 2a/2c, and Trial 3a/3d), there was no difference in cephalometric values between the common and the local arm. There were no statistically significant differences in the SNA and ANB angles between the common arm in Trial 1a (mean SNA 77.8, mean ANB 2.6) and Trial 2a (mean SNA 79.8, mean ANB 3.6) and no difference between Trial 1a and Trial 3a, but a statistical difference could be seen between Trial 2a and Trial 3a (mean SNA 76.9, mean ANB 1.7). However, the confidence interval was rather large. Intra- and inter-rater reliability were within acceptable range. CONCLUSIONS:The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned. REGISTRATION:ISRCTN29932826. PROTOCOL:The protocol was not published before trial commencement.
目的: 根据不同的手术方案，评估scandrash项目中 8 岁时颅面生长的差异。 设计和地点: 前瞻性、随机、对照临床试验 (RCT)，涉及 10 个中心，包括非综合征性白种人单侧唇腭裂 (ulp)。在试验 1 中，一种常用的手术方法 (1a) 在 3-4 个月大的时候关闭软腭，在 12 个月大的时候关闭硬腭，在 36 个月的时候接受类似手术的测试，但是在硬腭修复 (延迟硬腭关闭) (1b)。在试验 2 中，测试了普通方法 (2a) 在 1 年 (2c) 时同时关闭硬腭和软腭。在试验 3 中，对普通方法 (3a) 进行了 3 个月龄时硬腭闭合联合唇闭合和 1 岁时软腭闭合 (3d) 的测试。参与者通过使用骰子随机分配。操作者盲法是不可能的，但所有结果的所有评价者均盲法。 对象和方法: 8 岁时参与的患者总数为 429 例。分析头颅侧位片 (n = 408)。选择头影测量角度SNA和ANB评估这部分演示的上颌骨生长。 结果: 在每个试验 (试验 1a/1b、试验 2a/2c和试验 3a/3d) 中，普通臂和局部臂的头影测量值无差异。试验 1a (平均SNA 77.8，平均ANB 2.6) 和试验 2a (平均SNA 79.8，平均ANB 3.6) 中常见臂之间的SNA和ANB角度无统计学显著差异试验 1a和试验 3a之间没有区别，但试验 2a和试验 3a之间存在统计学差异 (平均SNA 76.9，平均ANB 1.7)。然而，置信区间相当大。评定者内和评定者间信度在可接受范围内。 结论: 就UCLP的生长结局 (SNA和ANB) 而言，时机和手术方法并不重要。 注册: isrctn29932826。 议定书: 议定书在试验开始前没有公布。
METHODS:BACKGROUND:The anterior oronasal fistulae neighboring the alveolar cleft could persist or reappear after the alveolar reconstruction with cancellous bone grafting. The persistent symptomatic anterior oronasal fistulae need to be repaired, but surgery remains a challenge in cleft care. Surprisingly, this issue has rarely been reported in the literature. The purpose of this long-term study was to report a single surgeon experience with a therapeutic protocol for persistent symptomatic anterior oronasal fistula repair. METHODS:This is a retrospective study of consecutive patients with Veau type III and IV clefts and persistent symptomatic anterior oronasal fistulae managed according to a therapeutic protocol from 1997 to 2018. Depending on fistula size, patients were treated with local flaps associated with an interpositional graft or two-stage tongue flaps (small/medium or large fistulae, respectively). The surgical outcomes were classified as "good" (complete fistula closure with no symptoms), "fair" (asymptomatic narrow fistula remained), or "poor" (failure with persistent symptoms). RESULTS:Forty-four patients with persistent symptomatic anterior oronasal fistulae were reconstructed with local flaps associated with interpositional fascia or dermal fat grafting (52.3%) or two-stage tongue flaps (47.7%). Most of patients (93.2%) presented "good" outcomes, ranging from 87% to 100% (local and tongue flaps, respectively). Three (6.8%) patients presented symptomatic residual fistula ("poor" outcomes). CONCLUSIONS:For the repair of persistent symptomatic anterior oronasal fistulae, this therapeutic protocol provided satisfactory outcome with low fistula recurrence rate.
METHODS:OBJECTIVE:Methadone is a vital treatment for women with opioid use disorder in pregnancy. Previous reports suggested an association between methadone exposure and Pierre Robin sequence (PRS), a rare craniofacial anomaly. We assessed the association between gestational methadone exposure and PRS. DESIGN/SETTING:This case-malformed control study used European Surveillance of Congenital Anomalies population-based registries in Ireland, the Netherlands, Italy, Switzerland, Croatia, Malta, Portugal, Germany, Wales, Norway and Spain, 1995-2011. PATIENTS:Cases included PRS based on International Classification of Disease (ICD), Ninth Edition-British Paediatric Association (BPA) code 75 603 or ICD, Tenth Edition-BPA code Q8708. Malformed controls were all non-PRS anomalies, excluding genetic conditions, among live births, fetal deaths from 20 weeks' gestation and terminations of pregnancy for fetal anomalies. An exploratory analysis assessed the association between methadone exposure and other congenital anomalies (CAs) excluding PRS. Methadone exposure was ascertained from medical records and maternal interview. RESULTS:Among 87 979 CA registrations, there were 127 methadone-exposed pregnancies and 336 PRS cases. There was an association between methadone exposure and PRS (OR adjusted for registry 12.3, 95% CI 5.7 to 26.8). In absolute terms, this association reflects a risk increase from approximately 1-12 cases per 10 000 births. A raised OR was found for cleft palate (adjusted OR 5.0, 95% CI 2.7 to 9.2). CONCLUSIONS:These findings suggest that gestational methadone exposure is associated with PRS. The association may be explained by unmeasured confounding factors. The small increased risk of PRS in itself does not alter the risk-benefit balance for gestational methadone use. The association with cleft palate, a more common CA, should be assessed with independent data.
METHODS::Orthopedic treatment to improve deficient maxillary growth of cleft lip and palate patients is an important part of treatment. The success of this treatment is strongly dependent on the time of initiation of therapy. There has been a large controversy in the available literature regarding the skeletal age of these patients. The aim of the present study was to compare the skeletal age of cleft lip and palate patients with normal individuals.37 unilateral and 14 bilateral cleft lip and palate patients and 47 healthy individuals participated in this cross-sectional study. The patients were classified into 8 to 10 and 11 to 14-year-old individuals. Cervical vertebral maturational stage of participants was evaluated in the lateral cephalometry. The skeletal age of cleft lip and palate patients was compared with normal controls. Chi-square was used for statistical analysis. There was not a significant difference in the skeletal developmental stage of unilateral and bilateral cleft compared to their normal peers according to their age and sex. Also, significant difference in skeletal maturational stage of cleft lip and palate patients was not found between boys and girls (P = 0.8). Similarly, no significant difference was found in the skeletal age of the 3 studied groups without considering the age and sex of participants (P = 0.5). Regarding the similar skeletal maturational stage of cleft lip and palate patients with normal controls in our study, their maxillofacial orthopedic treatment can be initiated at similar time to normal peers.