Virtual Surgical Guidance Improves Quality of Life Following Scapular Free-Flap Reconstruction of Maxillary Defects.

[BACKGROUND] The best approach to maxillary reconstruction with negative impact on the patient's quality of life (QOL) remains the subject of debate.

[PURPOSE] This study was designed to evaluate the QOL outcomes following maxillary reconstruction using a scapular-free flap, with and without the computer-aided design and computer-aided manufacturing (CAD/CAM) technique.

[STUDY DESIGN, SETTING, SAMPLE] A prospective randomized controlled clinical trial was performed following the CONSORT checklist. To be included, patients suffering from maxillary defects without previous surgery or lymph node involvement were selected. Patients with poor oncological prognosis, deficient performance status, preoperative chemotherapy, or radiotherapy, besides vascular contraindications, were excluded.

[PREDICTOR VARIABLE] The predictor variable was the reconstruction technique, grouped into two equal categories. Patients were randomly assigned to reconstruction with a scapular-free flap, with the control group not utilizing a guide and the study group utilizing a CAD/CAM-customized guide.

[MAIN OUTCOME VARIABLE] The primary outcome variable was the various domains of QOL, measured using the University of Washington Quality of Life score, 12 months after reconstruction.

[COVARIATES] Age; sex; scapular flap side; and maxillary defect tumour type, histopathology, side, length, class, sagittal, and axial differential areas were considered.

[ANALYSES] Shapiro-Wilk and Kolmogorov-Smirnov tests were performed for normality. For comparisons between the two groups, Student's t-test and Mann-Whitney test were used. The category variables were compared using the χ test. P ≤ .05 was considered statistically significant.

[RESULTS] The sample was composed of twenty-two eligible patients, eleven in each group. The mean age of the control group was (50.09 ± 17.14) years, and 45.45% were male, while in the study group, the mean age was (48.36 ± 14.14) years, with 36.36% male. All the patients were evaluated, showing statistically significant differences between control and study groups in terms of pain, appearance, chewing, swallowing, speech, and shoulder (P ≤ .05), indicating that the scapular-free flap with a CAD/CAM osteotomy guide had improved the patient's QOL.

[CONCLUSION AND RELEVANCE] The findings of this study indicate that virtual surgical planning with a CAD/CAM customized osteotomy guide using a scapular-free flap can improve QOL in maxillary reconstruction in terms of pain, appearance, chewing and swallowing food, pronouncing words, and shoulder QOL outcomes.