Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer

The primary outcome is the percentage of participants reaching a composite MDADI score of 80 (cohorts 1 and 2) or 60 (cohort 3) at 12 weeks after surgery. All participants complete the MDADI questionnaire at screening and at the 12-week post-operative visit to assess swallowing function, safety, and quality of life related to dysphagia.

Composite MDADI scores will be assessed at screening, 6, 12, and 24 months post-surgery to evaluate the long-term effect of intensive and personalized SSVR on swallowing function.

Dietary intake will be assessed using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from 1 to 7. Score is rated on 7 when patient tolerates total normal diet with no restrictions.

Dietary consistency will be assessed using the International Dysphagia Diet Standardisation Initiative (IDDSI) framework, which classifies food and drink textures into levels ranging from 0 (thin liquids) to 7 (regular foods). Higher levels indicate more advanced diet textures.

Swallow safety will be assessed using the Penetration-Aspiration Scale (PAS). It is an 8-point scale (no unit) used to characterize the depth and response to airway invasion during swallowing. Higher scores indicate worse swallow safety.

Qualitative parameters will be assessed using VFSS: recording of the total number of swallows per bolus, evaluation of residue in the valleculae and piriform sinuses with the Eisenhuber scale (0-3, no unit).

Swallow reaction time (SRT) will be quantitatively assessed using videofluoroscopic swallow study (VFSS). Unit of Measure: Milliseconds (ms)

Laryngeal vestibule closure reaction time (LVCrt) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms).

Pharyngeal transit time (PTT) will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms).

Upper esophageal sphincter (UES) opening duration will be quantitatively assessed using VFSS. Unit of Measure: Milliseconds (ms)

Hyoid elevation (HE) in millimeter (mm) will be assessed using VFSS.

Laryngeal ascension amplitude (mm) will be assessed using VFSS.

normalized maximum width of upper esophageal sphincter (UES) opening (%) will be assessed using VFSS.

Pharyngeal area at maximum dilation (cm²) will be assessed using VFSS.

Pharyngeal constriction ratio (PCR, %) will be assessed using VFSS.

Swallow efficiency: measured with the Normalized Residue Ratio Scale valleculae (NRRSv)

Swallow efficiency: measured with the Normalized Residue Ratio Scale piriform (NRRSp)

Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the GRBAS scale : (G(rade) of hoarseness, R(oughness), B(reathliness), A(esthenia) weakness, and S(train).

Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Maximum Phonation Time (MPT) (seconds).

Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Jitter (variations in signal frequency) %.

Voice will be assessed at screening, weeks 4, 12, and months 6, 12, 24 using the Shimmer (variation in signal amplitude) %.

Post-operative complications will be assessed using the Clavien-Dindo classification, a grading system ranging of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) and if the patient suffers from a complication at the time of discharge, the suffix "d" (for "disability") is added to the respective grade of complication. The grade I corresponds to any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological intervention and the grade V corresponds to the death of the patient.

Classification System for Postoperative Hemorrhage is graded as normal, minor, intermediate, major, or severe. The definition of normal is patient noting the presence of blood tinged mucus, flecks of blood, brown mucus, or red streaks, and the severe bleeding corresponds to bleeding resulting in life-threatening medical complications.

Local-regional control is defined as the time interval between the date of the 3-month mandatory imaging after the surgery and the date of local disease is detected. Local recurrence is defined as recurrence at the original primary tumor subsite or within 2 cm of distance from the primary tumor site. Regional recurrence is defined as recurrence at the cervical lymph node. The Time to first loco-regional recurrence (months) is assessed for cohorts 1 and 2.

distant control is defined as the time interval between the date of the 3-month mandatory imaging if the patient after the surgery and the first date when distant disease is detected. Distant recurrence is defined as recurrence not considered as local or regional. Time to first distant recurrence (months) is assessed for cohorts 1 and 2.

Second primary head and neck cancer control is defined as the time interval between the date of surgery and the date of diagnosis of a second cancer in the head and neck region, but outside the original primary tumor subsite (months) for cohorts 1 and 2.

Disease-free survival is defined as the time interval between the date of surgery and tumor recurrence or death from any cause (months) for cohort 1 and 2.

Disease-specific survival is defined as the time interval between the date of surgery and the date of death due to original primary disease (months) for cohort 1 and 2.

Overall survival is defined as the time interval between the date of surgery and the date of death from any cause (months) for cohort 1 and 2.

Percentage of participants with negative (>3 mm), close (1-3 mm), and positive (<1 mm) surgical margins will be recorded post-surgery.

Participants will complete the EORTC QLQ-HN43 questionnaire at screening, week 12, and months 6, 12, 24 to assess health-related quality of life.