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.
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.
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explicitly propose to withdraw but stop receiving treatment and tests and are lost to follow-up are also considered "withdrawn" (or "lost to follow-up").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.
Parallel
Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction
Procedure/SurgeryIntervention Description: Assisted oral cancer resection and defect reconstruction using MR technology based on UE5 engine, to achieve real-time stereoscopic visualization of surgical planning, accurate tumor resection and personalized free flap harvest, ensuring the reconstructed flap matches the defect site in morphology and volume.
Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction
Procedure/SurgeryIntervention Description: Assisted oral cancer resection and defect reconstruction using virtual surgical guide technology, with surgery performed under the guidance of preoperatively designed and fabricated guides to improve surgical standardization.
Morphological and Volumetric Matching Degree of Free Flap Reconstruction
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.
Surgery-related Indicators
The operative duration and utilization rate of harvested free flaps will be recorded in the three groups to evaluate the impact of different adjuvant technologies on surgical efficiency.
Postoperative Recovery Indicators
The free flap survival rate and primary wound healing rate will be counted in the three groups; the incidence of postoperative complications will be observed to evaluate surgical safety and reconstruction efficacy.
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