Hu Yu, Liu Jiagang, Chen Haifeng, Jiang Shu, Li Qiang, Fang Yuan, Gong Shuhui, Wang Yuelong, Huang Siqing
Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
BMJ Open. 2015 Apr 29;5(4):e007869. doi: 10.1136/bmjopen-2015-007869.
Chiari malformation type I (CM-I) is a congenital hindbrain anomaly that requires surgical decompression in symptomatic patients. Posterior fossa decompression with duraplasty (PFDD) has been widely practiced in Chiari decompression, but dural opening carries a high risk of surgical complications. A minimally invasive technique, dural splitting decompression (DSD), preserves the inner layer of the dura without dural opening and duraplasty, potentially reducing surgical complications, length of operative time and hospital stay, and cost. If DSD is non-inferior to PFDD in terms of clinical improvement, DSD could be an alternative treatment modality for CM-I. So far, no randomised study of surgical treatment of CM-I has been reported. This study aims to evaluate if DSD is an effective, safe and cost-saving treatment modality for adult CM-I patients, and may provide evidence for using the minimally invasive procedure extensively.
DECMI is a randomised controlled, single-masked, non-inferiority, single centre clinical trial. Participants meeting the criteria will be randomised to the DSD group and the PFDD group in a 1:1 ratio. The primary outcome is the rate of clinical improvement, which is defined as the complete resolution or partial improvement of the presenting symptoms/signs. The secondary outcomes consist of the incidence of syrinx reduction, postoperative morbidity rates, reoperation rate, quality of life (QoL) and healthcare resource utilisation. A total of 160 patients will be included and followed up at 3 and 12 months postoperatively.
The study protocol was approved by the Biological and Medical Ethics Committee of West China Hospital. The findings of this trial will be published in a peer-reviewed scientific journal and presented at scientific conferences.
ChiCTR-TRC-14004099.
I型Chiari畸形（CM-I）是一种先天性后脑异常，有症状的患者需要进行手术减压。后颅窝减压并硬脑膜成形术（PFDD）在Chiari减压手术中已被广泛应用，但打开硬脑膜会带来较高的手术并发症风险。一种微创技术，即硬脑膜劈开减压术（DSD），在不打开硬脑膜和不进行硬脑膜成形术的情况下保留硬脑膜内层，有可能减少手术并发症、缩短手术时间和住院时间，并降低成本。如果DSD在临床改善方面不劣于PFDD，那么DSD可能成为CM-I的一种替代治疗方式。到目前为止，尚未有关于CM-I手术治疗的随机研究报告。本研究旨在评估DSD对于成年CM-I患者是否是一种有效、安全且节省成本的治疗方式，并可能为广泛使用这种微创手术提供证据。
DECMI是一项随机对照、单盲、非劣效性、单中心临床试验。符合标准的参与者将按1:1的比例随机分为DSD组和PFDD组。主要结局是临床改善率，定义为当前症状/体征完全缓解或部分改善。次要结局包括空洞缩小发生率、术后发病率、再次手术率、生活质量（QoL）和医疗资源利用情况。总共将纳入160例患者，并在术后3个月和12个月进行随访。
本研究方案已获得四川大学华西医院生物医学伦理委员会的批准。本试验的结果将发表在同行评审的科学期刊上，并在科学会议上展示。
ChiCTR-TRC-14004099。
