Prospective Clinical Study in Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology Based on UE5 Engine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Morphological and Volumetric Matching Degree of Free Flap Reconstruction
研究概览
简要总结
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and defect reconstruction, accurate oral cancer resection, and precise morphological and volumetric matching of the reconstructed free flap to the defect site.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group.
The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
详细描述
Study population: Patients with oral cancer confirmed by preoperative pathology (tumor diameter > 3 cm), who had defects suitable for free flap reconstruction, signed written informed consent, agreed to complete postoperative follow-up, and were medically eligible for major surgery. This study was conducted at the Department of Oral and Maxillofacial-Head and Neck Oncology, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
The study is conducted at the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.
Primary research questions & outcome assessments:
- Whether UE5-based MR technology enables precise morphological and volumetric matching of free flaps in oral cancer reconstruction.
- Comparisons of operative duration, flap characteristics (utilization, volume, survival), and primary wound healing rate between mixed reality (MR), virtual surgical guide, and conventional surgery.
- Whether MR technology can overcome the limitations of virtual surgical guide systems and further enhance surgical efficiency and precision.
Researchers adopted a parallel controlled design, with participants randomized into three groups: Experimental Group 1 (undergoing Mixed Reality [MR] technology-assisted surgery), Experimental Group 2 (undergoing virtual surgical guide-assisted surgery), and Control Group (undergoing conventional surgery). A total of 30 participants will be recruited, with 10 cases in each group. The primary purpose is to confirm the effectiveness of MR technology in assisting oral cancer resection, free flap design, harvest, and defect reconstruction. Allocation concealment will be implemented via the sealed envelope method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite pathological diagnosis of oral cancer before surgery;
- •Defects suitable for free flap reconstruction;
- •Patients have signed the informed consent form and are willing to cooperate with postoperative follow-up.
排除标准
- •- Poor general condition, evaluated as unable to tolerate surgical treatment.
- •Exclusion Criteria (After Enrollment)
- •Subjects who have been enrolled in this trial will be excluded if they meet any of the following conditions:
- •Violation of important inclusion criteria;
- •Subjects did not receive surgical treatment;
- •No observation data after randomization. Withdrawal Criteria Withdrawal of subjects from the trial refers to cases where enrolled subjects are determined by the investigator to withdraw from the trial due to conditions that make it inappropriate to continue the trial. In accordance with the informed consent form, subjects have the right to withdraw from the trial midway. Subjects who do not explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered "withdrawn" (or "lost to follow-up"). The reason for withdrawal should be understood and recorded as much as possible, such as: poor subjective curative effect; inability to tolerate certain adverse reactions; inability to continue participating in the clinical study due to personal reasons; economic factors; or lost to follow-up without stating the reason.
- •(1) Aggravation or deterioration of the condition during the trial that requires emergency measures; (2) Occurrence of certain comorbidities, complications or special physiological changes in subjects during the trial, making it inappropriate to continue participating in the trial; (3) Voluntary withdrawal by the subject.
- •Data Handling of Withdrawn Subjects
- •Regardless of the reason, the complete clinical data of subjects who withdraw from the trial shall be retained. For all withdrawn subjects, the trial conclusion form and the reason for withdrawal shall be filled in the case report form (CRF). Generally, there are 6 types of reasons: occurrence of adverse events (including adverse drug reactions and allergic reactions), lack of efficacy (deterioration of condition or occurrence of complications), violation of the trial protocol (including poor compliance), lost to follow-up (including voluntary withdrawal by the patient), termination by the sponsor, or others.
研究组 & 干预措施
Control Group (Conventional Surgery)
Adoption of traditional surgical methods for oral cancer resection and defect repair; no auxiliary technologies such as mixed reality or virtual guides are used, and tumor resection and flap repair are completed relying on the clinician's clinical experience.
Experimental Group 1 (Mixed Reality Technology)
Application of Mixed Reality (MR) technology based on the UE5 engine to assist in oral cancer resection and defect repair; realize real-time three-dimensional visualization of surgical plans, precise resection of oral cancer, "tailor-made" flap harvesting, and match the shape and volume of the defect site.
干预措施: Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction (Procedure)
Experimental Group 2 (Virtual Surgical Guide)
Application of virtual surgical guide technology to assist in oral cancer resection and defect repair; assist surgery relying on pre-designed and manufactured guides to improve surgical standardization; guide printing is required before surgery, and the plan cannot be adjusted in real time during surgery.
干预措施: Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction (Procedure)
结局指标
主要结局
Morphological and Volumetric Matching Degree of Free Flap Reconstruction
时间窗: Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively
Description: Computed Tomography (CT) scans will be performed at 1 month and 6 months postoperatively. CT data will be fused with the preoperative design scheme to calculate morphological similarity (expressed as a percentage), so as to evaluate the morphological and volumetric matching effect between the reconstructed flap and the defect site in the three groups. The core purpose is to compare the precision of MR technology with the other two methods.
次要结局
- Postoperative Recovery Indicators(Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively)
- Surgery-related Indicators(Preoperatively 2 weeks ± 3 days postoperatively 1 month ± 7 days postoperatively 3 months ± 2 weeks postoperatively 6 months ± 1 month postoperatively)
研究者
Mingming Lv
Associate Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University