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临床试验/DRKS00022397
DRKS00022397已完成不适用

Patient-specific 3D Liver model- based patient information for liver surgery - 3D-LiMo Trial

Technische Universität Dresden0 个研究点目标入组 40 人开始时间: 2020年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40

研究概览

简要总结

Results The study population (n = 40) was predominantly of male gender (62.5%) with a median age of 65.2 years and a high prevalence of preexisting diseases. Underlying disease, warranting hepatobiliary surgery, was malignancy in the majority of cases (97.5%). Patients in the 3D-LiMo group were more likely to feel very thoroughly educated and exhibited a higher level of satisfaction following surgical education than the control group (80 vs. 55%, n.s.; 90 vs. 65%, n.s.; respectively). Applying 3D models was also associated with enhanced understanding of the underlying disease with regard to amount (100% vs. 70%, p = 0.020) and location of liver masses (95 vs. 65%, p = 0.044). 3D-LiMo patients also demonstrated enhanced understanding of the surgical procedure (80 vs. 55%, n.s.), leading to better awareness for the occurrence of postoperative complications (88.9, vs. 68.4%, p = 0.052). Adverse event profiles were similar. Conclusion In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education and facilitate patients’ understanding of the surgical procedure as well as awareness of postoperative complications. Therefore, the study protocol is feasible to apply to an adequately powered, multicenter, randomized clinical trial with minor modifications.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Indication for liver resection
  • - Preoperative imaging in the form of a KM-CT or -MRT available

排除标准

  • - speech problems or impaired mental state
  • - missing compliance

研究者

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