Paediatric Surgery

儿科手术
  • 文章类型: Journal Article
    在这项前瞻性随机对照试验中,我们比较了侧卧位和仰卧位在腹内手术后2个月至2年的婴儿气管拔管时对拔管后可能发生的呼吸不良事件发生率的影响.麻醉方案是标准化的。在包括的120名婴儿中(每组60名),两组的人口统计学数据和围手术期数据具有可比性.仰卧位和侧卧位组气管拔管后围手术期呼吸不良事件发生率分别为21.6%和5%,分别,p=0.007,比值比=3.87;95%置信区间:1.18-12.6。侧卧位也降低了气道阻塞的发生率,p=0.004,比值比=11.8;95%置信区间:1.46-95.3,氧饱和度低于92%,p=0.008,比值比=11.8;95%置信区间:1.46-95。侧卧位似乎对婴儿气管拔管实用且有益。
    In this prospective randomised controlled trial, we compared the impact of the lateral versus supine position for tracheal extubation among infants aged two months to two years after intraabdominal surgery on the incidence of respiratory adverse events that may occur after extubation. The anaesthesia protocol was standardised. Among the 120 infants included (60 in each group), the demographic and perioperative data were comparable between both groups. The incidence of perioperative respiratory adverse events after tracheal extubation was 21.6% and 5% in the supine and lateral position groups, respectively, with p = 0.007 and odds ratio = 3.87; 95% confidence interval: 1.18-12.6. Lateral position also reduced the incidence of airway obstruction with p = 0.004 and odds ratio = 11.8; 95% confidence interval: 1.46-95.3 and oxygen desaturation below 92% with p = 0.008 and odds ratio = 11.8; 95% confidence interval: 1.46-95. The lateral position seems to be practical and beneficial for tracheal extubation among infants.
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  • 文章类型: Journal Article
    困难的气道管理是儿科麻醉的主要挑战之一,特别是在低收入和中等收入国家。
    本研究的目的是探讨儿科插管困难的主要预测因素。
    在这项观察性研究中,我们纳入了所有5岁以下接受气管插管的腹内手术的儿童.根据插管困难的发生率将患者分为两组。然后,我们调查了儿科困难插管的预测因素.
    我们包括217个孩子,在其中10%的患者中观察到困难的插管。预测因素如下:MallampatiIII-IV级(调整后的比值比=2.21;95%置信区间=1.1-6.4),张口受限(调整后的赔率比=2.4;95%置信区间=1.8-3.5),面部畸形(调整后的比值比=2.6;95%置信区间=1.32-7.4)和无肌肉松弛剂麻醉(调整后的比值比=1.8;95%置信区间=1.0-5.1)或无阿片类药物麻醉(调整后的比值比=1.7;95%置信区间=1.01-4.8).
    面部畸形和张口受限是儿童插管困难的预测因素。此外,Mallampati类和麻醉技术似乎也可以预测具有挑战性的插管,这可能会指导我们改变围手术期的做法。
    UNASSIGNED: Difficult airway management is one of the main challenges in paediatric anaesthesia, particularly in low- and middle-income countries.
    UNASSIGNED: The aim of this study was to investigate the main predictors of difficult paediatric intubation.
    UNASSIGNED: In this observational study, we included all children aged less than five years undergoing intra-abdominal surgery with endotracheal intubation. Patients were divided into two groups according to the incidence of difficult intubation. Then, we investigated predictors for difficult paediatric intubation.
    UNASSIGNED: We included 217 children, and difficult intubation was observed in 10% of them. Predictors were as follows: Mallampati III-IV class (adjusted odds ratio = 2.21; 95% confidence interval = 1.1-6.4), limited mouth opening (adjusted odds ratio = 2.4; 95% confidence interval = 1.8-3.5), facial dysmorphia (adjusted odds ratio = 2.6; 95% confidence interval = 1.32-7.4) and anaesthesia without muscle relaxant (adjusted odds ratio = 1.8; 95% confidence interval = 1.0-5.1) or without opioids during crash inductions (adjusted odds ratio = 1.7; 95% confidence interval = 1.01-4.8).
    UNASSIGNED: Facial dysmorphia and limited mouth opening were predictors of difficult intubation in children. Furthermore, it seems that Mallampati class and anaesthesia technique may also predict challenging intubation, which may guide us to change our perioperative practice.
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  • 文章类型: Journal Article
    背景:与工作相关的肌肉骨骼疾病的患病率不断上升,金融,以及对外科医生的心理影响。这项研究旨在确定使用可穿戴姿势设备是否可以改善在次优状态下花费的操作时间,高风险姿势。
    方法:在这项前瞻性随机研究的第一阶段招募了外科医生,并获得了基线姿势数据。在第2阶段,参与者被随机分配接受传统的教育研讨会或设备的术中振动,以纠正姿势失误。在次要选修日案件中,收集术中姿势数据并按前屈角分层,分为五个风险类别(可忽略到非常高)。还评估了参与者使用传感器的经验。
    结果:共有100例外科手术(第1阶段:n=50;第2阶段:n=50)由8名不同资历的外科医生进行。暴露于教育干预增加了在次优姿势中花费的时间(第1阶段与阶段2);47.5%与67.8%,p=0.05。然而,这次振动干预显着减少;50.0%vs.20.7%,p=0.005。程序类型没有影响姿势,虽然,腹腔镜干预在风险可忽略的姿势中花费的时间最多;47.7%vs.49.3%,与开放程序相比。与同事/注册师相比,手术顾问在次优姿势上花费的时间更少;30.3%vs.72.6%(第一阶段)和33.8%65.3%(第二阶段)。
    结论:设备的振动干预显着减少了在次优状态下花费的时间,高风险姿势。由于手术类型与姿势变化不相关,调节姿势的外科医生特定因素至关重要。最后,外科医生经验与改善的手术人体工程学呈正相关。
    BACKGROUND: The rising prevalence of work-related musculoskeletal disorders has numerous physical, financial, and mental repercussions for surgeons. This study aims to establish whether the use of a wearable posture device can improve the operating time spent in suboptimal, high-risk postures.
    METHODS: Surgeons were recruited in Phase 1 of this prospective randomised study and baseline postural data was obtained. In Phase 2, participants were randomised to receive either a traditional educational workshop or intraoperative vibrations from the device to correct postural lapses. During minor elective day cases, intraoperative postural data was collected and stratified by forward flexion angle, into five risk categories (negligible to very high). Participants\' experience with the sensor was also assessed.
    RESULTS: A total of 100 surgical procedures (Phase 1: n = 50; Phase 2: n = 50) were performed by eight surgeons of varying seniority. Exposure to the educational intervention increased time spent in suboptimal posture (Phase 1 vs. Phase 2); 47.5% vs. 67.8%, p = 0.05. However, the vibrational intervention significantly reduced this time; 50.0% vs. 20.7%, p = 0.005. Procedure type didn\'t influence posture although, laparoscopic interventions spent most time in negligible-risk postures; 47.7% vs. 49.3%, compared to open procedures. Surgical consultants spent less time in suboptimal posture compared to fellow/registrars; 30.3% vs. 72.6% (Phase 1) and 33.8% vs. 65.3% (Phase 2).
    CONCLUSIONS: Vibrational intervention from the device significantly decreased the time spent in suboptimal, high-risk postures. As procedure type wasn\'t correlated with postural changes, surgeon-specific factors in regulating posture are paramount. Finally, surgeon experience was positively correlated with improved surgical ergonomics.
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  • 文章类型: Journal Article
    背景:关于低收入和中等收入国家(LMICs)儿科手术状况的文献仍然有限。作为一种常见的紧急情况,睾丸扭转的及时治疗是儿科手术中提供足够紧急服务的基准。这项范围研究旨在综合所有有关LMICs小儿睾丸扭转的现有文献。
    方法:OxPLORE全球儿科外科研究小组进行了数据库搜索,以确定包含源自LMIC的术语“睾丸扭转”或“急性阴囊”的研究。对搜索结果进行了专题分析,并对所有纳入的文章进行了证据质量评估。
    结果:本综述包括17项研究,共1798例患者。所有研究都来自中等收入国家,大多数(76%)的样本量小于100名患者。所有研究均被评估为提供的证据不足。纳入的研究确定了治疗的长期延误,并强调了关于评分系统和多普勒超声检查在诊断扭转中的价值的持续辩论。还观察到了治疗儿童睾丸扭转的手术方法的主要异质性。
    结论:关于LMICs患儿睾丸扭转的文献很少且不均匀。前瞻性,迫切需要多中心研究这种常见的儿科外科紧急情况的管理。
    BACKGROUND: Literature on paediatric surgical conditions in low- and middle-income countries (LMICs) remains limited. As a common emergency, timely treatment of testicular torsion acts as a benchmark of adequate emergency service delivery in paediatric surgery. This scoping study aims to synthesise all existing literature on paediatric testicular torsion in LMICs.
    METHODS: A database search was conducted by the OxPLORE global paediatric surgery research group to identify studies containing the terms \'testicular torsion\' or \'acute scrotum\' originating from LMICs. A thematic analysis was applied to the results of the search and the quality of evidence was appraised for all included articles.
    RESULTS: This review included 17 studies with 1798 patients. All studies originated from middle-income countries and the majority (76%) had sample sizes smaller than 100 patients. All studies were appraised as providing less than adequate evidence. Included studies identified long delays to treatment and highlighted ongoing debates on the value of scoring systems and Doppler ultrasonography in diagnosing torsion. Major heterogeneity in surgical approaches to treatment of testicular torsion in children was also observed.
    CONCLUSIONS: Literature on paediatric testicular torsion in LMICs is scarce and heterogeneous. Prospective, multi-centre research on the management of this common paediatric surgical emergency is urgently required.
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  • 文章类型: Journal Article
    术后疼痛是儿童手术常见且令人痛苦的后果。它可以导致痛苦,长时间恢复,身体功能受损,甚至慢性疼痛。有效的术后疼痛管理对于改善患者预后至关重要。然而,有几个因素阻碍了儿童疼痛的准确评估和管理,特别是在低收入国家。本研究旨在评估儿科患者术后疼痛的严重程度并确定其预测因素。
    于2023年1月至4月在亚的斯亚贝巴公立医院对235名2个月-7岁的儿科手术患者进行了纵向研究。主要结果,疼痛严重程度,使用疼痛评估工具在三个不同的时间进行评估。Cochran的q检验用于比较术后疼痛发生率。广义估计方程用于确定随时间变化的预测变量对疼痛严重程度的影响。该研究证明了使用具有95%CI的AOR的相关性和显著性的方向,P值为0.05。
    术后12h中重度疼痛发生率为36.6%,24h时20%,36h时10%。术前疼痛和术前焦虑的患者更容易出现中度至重度术后疼痛[调整比值比(AOR)分别为3.41,CI=1.15,10.00和AOR=2.28,CI=1.219,4.277)。术后疼痛严重程度的术中预测因素包括手术持续时间较长(AOR=6.62,CI=1.90,23.00)和大手术(AOR=5.2,CI=2.11,12.88)。接受多模式镇痛的患者术后疼痛严重程度降低(AOR=0.24;CI=0.091,0.652),术后评估频繁的患者(AOR=0.09;CI=0.022,0.393)。
    本研究中相当一部分儿科手术患者术后疼痛程度较高,影响疼痛严重程度的最重要因素是术后疼痛管理策略和评估实践。
    UNASSIGNED: Postoperative pain is a common and distressing consequence of surgery in children. It can lead to suffering, prolonged recovery, impaired physical functioning, and even chronic pain. Effective postoperative pain management is crucial for improving patient outcomes. However, several factors hinder the accurate assessment and management of pain in children, particularly in low-income countries. This study aims to evaluate the severity of postoperative pain in paediatric patients and identify its predictors.
    UNASSIGNED: A longitudinal study was conducted on 235 paediatric surgical patients aged 2 months-7 years in Public Hospitals of Addis Ababa from January to April 2023. The primary outcome, pain severity, was assessed at three different times using a pain assessment tool. Cochran\'s q-test was used to compare postoperative pain incidences. The Generalized Estimating Equation was used to determine predictor variables\' effects on pain severity over time. The study demonstrated the direction of association and significance using an AOR with a 95% CI at a P value of 0.05.
    UNASSIGNED: The incidence of moderate to severe postoperative pain was 36.6% at 12 h, 20% at 24 h, and 10% at 36 h. Patients with preoperative pain and preoperative anxiety were more likely to experience moderate to severe postoperative pain [adjusted odds ratio (AOR)=3.41, CI=1.15, 10.00 and AOR=2.28, CI=1.219, 4.277, respectively). Intraoperative predictors of postoperative pain severity included longer duration of surgery (AOR=6.62, CI=1.90, 23.00) and major surgery (AOR=5.2, CI=2.11, 12.88). Postoperative pain severity was reduced in patients receiving multimodal analgesia (AOR=0.24; CI=0.091, 0.652) and in patients assessed frequently in the postoperative period (AOR=0.09; CI=0.022, 0.393).
    UNASSIGNED: A significant portion of paediatric surgical patients in this study experienced high levels of postoperative pain, particularly within the first 24 h. The most influential factors affecting pain severity were postoperative pain management strategies and assessment practices.
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  • 文章类型: Journal Article
    背景:由于缺乏高质量的临床证据,儿科患者长骨骨折和创伤性髋关节脱位的治疗存在管理争议和临床平衡。该方案描述了一项大型前瞻性全球多中心队列研究(注册表)的努力,旨在提供高质量的数据以协助循证治疗决策。
    方法:符合资格的儿科患者(N=750-1000)患有肱骨近端骨折的开放性骨折,肱骨远端骨折,桡骨近端骨折,前臂干骨折,创伤性髋关节脱位,股骨颈骨折或胫骨干骨折将在24-36个月的时间内招募.住院和治疗细节(包括材料和植入物)将被捕获在基于云的,可搜索的数据库。成果措施包括射线照相评估,临床结果(如运动范围,肢体长度差异和植入物移除),患者报告的结果(患者报告的骨折结果,患者报告的结果测量信息系统(PROMIS)和EuroQol-5D(EQ-5D-Y))和不良事件。除了患者人口统计学的描述性统计,基线特征,骨折类型和不良事件发生率,研究问题将根据数据的可用性和质量来制定。在进行统计分析之前,将准备统计分析计划。
    背景:在每个参与中心招募患者之前,将获得伦理批准。患者登记将遵循由负责的伦理委员会批准的知情同意程序。同行评审的出版物计划传播研究结果。
    背景:NCT04207892。
    BACKGROUND: Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.
    METHODS: Eligible paediatric patients (N=750-1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24-36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
    BACKGROUND: Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
    BACKGROUND: NCT04207892.
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  • 文章类型: Journal Article
    目的:小儿肱骨近端骨折(PHFs)历来非手术治疗。然而,多年来,大龄儿童中严重流离失所的PHF的管理一直存在争议,当代研究提倡手术。这项研究的目的是回顾一组接受PHF治疗的儿科患者的结果,以指导未来儿科PHF的管理。
    方法:回顾了南澳大利亚妇女儿童医院的记录,以确定2010年1月1日至2020年6月1日期间发生的儿科PHF。参与者完成了手臂的快速残疾,肩和手(QuickDASH),肩痛和残疾指数,和儿科结果数据收集仪器通过电话采访。使用Zoom通过远程健康评估参与者的肩部活动范围。多变量逻辑回归用于确定与较差预后相关的患者和临床变量。
    结果:在联系的307名患者中,125参加。46名患者符合较差临床结果的定义,定义为QuickDASH评分≥2。严重程度较高的骨折预示着较差的结果,受伤时年龄≥12岁的患者的QuickDASH总分较高。研究结果并不表明这些患者亚组如果手术治疗有更好的预后。
    结论:大多数儿科PHF具有可接受的临床结果,不管治疗方法如何。需要进行多中心前瞻性研究,以确定严重流离失所的PHF青少年患者的手术指征。
    OBJECTIVE: Paediatric proximal humerus fractures (PHFs) have historically been treated non-operatively. However, the management of severely displaced PHFs in older children has been debated over the years, with contemporary studies advocating for surgery. The purpose of this study was to review the outcomes of a cohort of paediatric patients treated for a PHF to guide management of future paediatric PHFs.
    METHODS: The records of the Women\'s and Children\'s Hospital in South Australia were reviewed to identify paediatric PHFs occurring between 1 January 2010 and 1 June 2020. Participants completed the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH), the Shoulder Pain and Disability Index, and the Paediatric Outcomes Data Collection Instrument via phone interview. Participants\' shoulder range-of-motion was assessed via telehealth using Zoom. Multivariable logistic regression was used to identify patient and clinical variables that were associated with a poorer outcome.
    RESULTS: Of 307 patients contacted, 125 participated. Forty-six patients met the definition of a poorer clinical outcome, defined as a QuickDASH score of ≥2. Fractures of greater severity were predictive of a poorer outcome, and patients aged ≥12 years old at the time of injury had higher total QuickDASH scores. The findings did not suggest that these subgroups of patients have superior outcomes if treated surgically.
    CONCLUSIONS: The majority of paediatric PHFs have an acceptable clinical outcome, irrespective of treatment methodology. Multicentre prospective studies are required to establish the indications for surgery for adolescent patients with severely displaced PHFs.
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  • 文章类型: Journal Article
    撒哈拉以南非洲经历了不成比例的儿科外科疾病,80%的儿童缺乏及时的机会,负担得起的,和安全的手术护理。本研究旨在描述康诺特医院儿科外科疾病的负担和结果,塞拉利昂主要的儿科转诊医院。
    这项回顾性和基于医院的研究包括2015年至2016年6月在弗里敦的康诺特医院接受手术的15岁以下儿童,塞拉利昂。描述性和推断性统计数据用于表征疾病的分布,并将所有变量与年龄类别和死亡率进行比较。
    本研究共纳入215例患者,其中72.5%(n=132)为男性,27.5%(n=50)为女性。大多数患者被诊断为先天性异常(60.9%;n=131)。然而,在5-10岁(n=38)的患者中,感染是主要诊断(60.5%;n=23).腹股沟疝是先天性异常患者的主要疾病(65.0%;n=85)。死亡率最高的情况是感染(17.0%;n=8),其次是其他疾病(9.1%;n=2)和先天性异常(3.1%;n=4)。根据这项研究的结果,在弗里敦,每年有超过7000名腹股沟疝儿童得不到治疗,塞拉利昂。
    这项研究量化了儿童外科疾病的负担,在国家卫生议程中优先考虑儿科外科护理的基础步骤,基于证据的干预措施的发展,以及塞拉利昂资源的战略分配。
    UNASSIGNED: Sub-Saharan Africa experiences a disproportionate amount of pediatric surgical disease, with 80% of children lacking access to timely, affordable, and safe surgical care. This study aims to characterize the burden of disease and outcomes of pediatric surgical conditions at Connaught Hospital, the main pediatric referral hospital in Sierra Leone.
    UNASSIGNED: This retrospective and hospital-based study included children up to 15 years old who were operated on between 2015 and June 2016 at Connaught Hospital in Freetown, Sierra Leone. Descriptive and inferential statistics were used to characterize the distribution of disease and compare all variables against age category and mortality.
    UNASSIGNED: A total of 215 patients were included in this study of which 72.5% (n=132) were male and 27.5% (n=50) were female. Most of the patients were diagnosed with congenital anomalies (60.9%; n=131). However, infection was the leading diagnosis (60.5%; n=23) among patients aged 5-10 years (n=38). Inguinal hernia was the leading condition (65.0%; n=85) among patients presenting with a congenital anomaly. The condition with the highest mortality was infections (17.0%; n=8), followed by other conditions (9.1%; n=2) and congenital anomalies (3.1%; n=4). Based on the results of this study, over 7000 children with inguinal hernias remain untreated annually in Freetown, Sierra Leone.
    UNASSIGNED: This study quantifies the burden of surgical disease among children, a foundational step toward the prioritization of pediatric surgical care in national health agendas, the development of evidence-based interventions, and the strategic allocation of resources in Sierra Leone.
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  • 文章类型: Journal Article
    背景:据说在肠吻合术后将儿童口服至肠道功能恢复可减少并发症。禁食可能会持续五天,有营养不良和使用肠外营养的风险。本研究旨在建立早期肠内营养在肠造口关闭患儿中的有效性和安全性。
    方法:对在2019年1月1日至2021年31月12日期间在两家三级儿科医院接受肠造口关闭的3个月至16岁儿童进行了回顾性队列研究。将24小时内(EEN)喂食清澈液体的儿童与以后开始喂食的儿童(LEN)进行比较。主要结局是术后住院时间(LOS),次要结局包括:进食时间;大便时间;和并发症。
    结果:在129名接受造口闭合的儿童中,69人符合纳入标准:LEN组35人(51%),EEN组34人(49%)。EEN组的儿童LOS明显较短(92.6hvs121.7h,p=0.0045)。早期进食还与获得游离液体的时间显着减少(p<0.001)和完全肠内摄入(p=0.007)有关。并发症无显著组间差异。
    结论:在造口闭合后24小时内开始喂食是有效且安全的,随着LOS的明显减少,吃饱的时间和大便的时间,没有增加并发症。需要进一步的研究将这些发现推断到其他人群。
    方法:III.
    BACKGROUND: Keeping children nil by mouth until return of bowel function after intestinal anastomosis surgery is said to reduce complications. Fasting may extend up to five days, risking malnourishment and usage of parenteral nutrition. This study aims to establish the efficacy and safety of early enteral nutrition in children undergoing intestinal stoma closure.
    METHODS: A retrospective cohort study of children aged three months to 16 years who underwent an intestinal stoma closure between 1/1/2019 and 31/12/2021 at two tertiary paediatric hospitals was undertaken. Children fed clear fluids within 24 h (EEN) were compared to those commencing feeds later (LEN). The primary outcome was length of post-operative stay (LOS) and secondary outcomes included: time to feeds; time to stool; and complications.
    RESULTS: Of the 129 children that underwent a stoma closure, 69 met inclusion criteria: 35 (51 %) in the LEN group and 34 (49 %) in the EEN group. Children in the EEN group had a significantly shorter LOS (92.6 h vs 121.7 h, p = 0.0045). Early feeding was also associated with a significantly decreased time to free fluids (p < 0.001) and full enteral intake (p = 0.007). There was no significant intergroup difference in complications.
    CONCLUSIONS: Commencing feeding within 24 h of stoma closure is efficacious and safe, with clear reductions in LOS, time to full feeds and time to stool, and no increase in complications. Further research is required to extrapolate these findings to other populations.
    METHODS: III.
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  • 文章类型: Journal Article
    背景:在儿童中,开放式腹股沟疝修补术一直是治疗的金标准,但是随着腹腔镜检查技术的进步,腹腔镜疝修补术越来越受欢迎。尽管有比较研究的结果,关于开腹与腹腔镜治疗策略的优越性仍未达成共识.缺乏共识的一个重要原因是试验报告的结果和结果定义的巨大异质性,这限制了研究之间的比较,并排除了有关治疗策略优越性的结论。核心结果集(COS)的开发和实施是选择中这种异质性的解决方案,跨研究的试验结果测量和报告。目前,没有用于治疗小儿腹股沟疝的COS。
    方法:本项目的目的是在研究儿童腹股沟疝修补术的所有未来临床试验中应测量和报告的最低限度结果方面达成国际共识。开发过程包括三个阶段。首先,我们从患者的角度,通过使用EMBASE对文献进行系统回顾,确定与小儿腹股沟疝修补术相关的结局领域。MEDLINE和Cochrane图书馆数据库。第二,我们进行了三步Delphi研究,以确定并优先考虑最终最小集的“核心”结果。在第三阶段,举行了一次专家会议,以建立最终的COS并与所有利益相关者团体的参与者制定实施策略:医疗保健专业人员,家长和患者代表。最终COS将根据COS报告标准声明进行报告。
    背景:阿姆斯特丹UMC的医学研究伦理委员会确认,《荷兰涉及人类受试者的医学研究法案》(WMO)不适用于本研究,并且不需要委员会的完全批准。将获得所有参与者的电子知情同意书。结果将在同行评审的学术期刊和相关会议上发表。
    CRD42021281422。
    In children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from comparative studies, there is still no consensus regarding the superiority of open versus laparoscopic treatment strategy. An important reason for lack of consensus is the large heterogeneity in the trials\' reported outcomes and outcome definitions, which limits comparisons between studies and precludes conclusions regarding the superiority of treatment strategies. The development and implementation of a core outcome set (COS) is a solution for this heterogeneity in the selection, measurement and reporting of trial outcome measures across studies. Currently, there is no COS for the treatment of paediatric inguinal hernia.
    The aim of this project is to reach international consensus on a minimal set of outcomes that should be measured and reported in all future clinical trials investigating inguinal hernia repair in children. The development process comprises three phases. First, we identify outcome domains associated with paediatric inguinal hernia repair from a patient perspective and through a systematic review of the literature using EMBASE, MEDLINE and the Cochrane Library databases. Second, we conduct a three-step Delphi study to identify and prioritise \'core\' outcomes for the eventual minimal set. In the third phase, an expert meeting is held to establish the final COS and develop implementation strategies with participants from all stakeholder groups: healthcare professionals, parents and patients\' representatives. The final COS will be reported in accordance with the COS-Standards for Reporting statement.
    The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at relevant conferences.
    CRD42021281422.
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