CLINICAL TRIAL OF FETAL SURGERY FOR DIAPHRAGMATIC HERNIA

患有严重疝气的胎儿，预计会死亡， 在出生前经过成功的手术修复后存活了下来。 虽然 27例早期开放式胎儿手术的经验总结 病变表明，子宫切除术是安全的母亲和她的 生殖潜力，这种侵入性治疗对任何给定的 如果没有控制的属性，就不能建立疾病过程 前瞻性试验 尽管道德上，后勤上，和财政上 分配或保留创新外科手术的困难 对于危及生命的胎儿状况，我们认为， 在其发展的早期确立这种有前途的新疗法的地位， 在没有经过科学检验的情况下， 我们建议进行临床试验，以评估 开放式胎儿手术治疗重症胎儿腹股沟疝 这将是一项随机对照试验，比较两组： 接受开放式胎儿手术（创新治疗组）和那些 接受标准围产期管理（标准治疗组）。 的 样本人群是患有疝的胎儿亚组 使用先前实验和临床研究中开发的标准进行选择 问题研究 孤立性左侧腹股沟疝伴大疝的胎儿 30岁以前，包括胃在内的内脏嵌顿在胸腔中的体积 怀孕几周是候选人。 主要结局变量为新生儿 mortality. 次要结果变量是反映长期 发病率、死亡率和成本分析。 统计分析将使用Chi- 新生儿死亡率和二分次级 结果变量。 将使用Student t检验和Mann-Whitney检验 连续的次要结果变量。 分析将采用 打算治疗修改和规定将肢体 如果主要结局出现统计学显著差异，则关闭 组间或随机分组组中是否发生孕产妇死亡 胎儿手术

Fetuses with severe diaphragmatic hernia, who would be expected to die, have survived after successful surgical repair before birth. Although the early experience with 27 cases of open fetal surgery for a variety of lesions suggests that hysterotomy is safe for the mother and her reproductive potential, the efficacy of this invasive therapy for any given disease process cannot be established without a property controlled prospective trial. Despite the ethical, logistical, and financial difficulties of assigning or withholding an innovative surgical procedure for a life threatening fetal condition, we believe that it is imperative to establish the place of this promising new therapy early in its development, before it becomes established without being scientifically tested. We propose to perform a clinical trial to assess the efficacy and safety of open fetal surgery in treating severe cases of fetal diaphragmatic hernia. This will be a randomized control trial comparing two groups: those receiving open fetal surgery (innovative treatment group) and those receiving standard perinatal management (standard treatment group). The sample populations are subgroups of fetuses with diaphragmatic hernia selected using criteria developed in previous experimental and clinical studies. Fetuses with isolated left diaphragmatic hernia with a large volume of viscera including stomach incarcerated in the chest before 30 weeks gestation are candidates. The primary outcome variable is neonatal mortality. Secondary outcome variables are parameters reflecting long-term morbidity, mortality and cost analysis. Statistical analysis will use Chi- square for comparison of neonatal mortality and dichotomous secondary outcome variables. Student's t-test and the Mann-Whitney test will be used for continuous secondary outcome variables. Analysis will employ an intention to treat modification and provisions will be made for limb closure if statistically significant differences in primary outcome occur between the groups or if maternal mortality occurs in the group randomized to fetal surgery.