Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer (NCT07546045) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Personalized Rehabilitation With Organ-Preserving Robotic RESA in Head and Neck Cancer
Switzerland53 participantsStarted 2026-05
Plain-language summary
This study aims to evaluate whether an intensive and personalized speech, swallowing, and voice rehabilitation (SSVR) program can help preserve swallowing function in patients with head and neck cancer undergoing minimally invasive robotic-assisted extended "Sistrunk" surgery (RESA).
Participants will undergo the RESA surgery as part of their standard care. After surgery, they will receive a structured SSVR program for 12 weeks, including daily exercises performed both with a speech therapist and independently. The program is tailored to each patient and adapted based on regular assessments of swallowing and voice function.
The study includes three groups of patients:
Those having surgery for a primary tumor Those having surgery for a recurrent or second primary tumor Patients treated for laryngeal elevation to improve swallowing after previous cancer treatment
The main goal is to assess whether this approach improves swallowing function measured by a validated questionnaire 12 weeks after surgery. Secondary outcomes include long-term swallowing, voice, diet, post-operative complications, surgical success, disease recurrence, survival, and quality of life.
All participants will be followed for two years with regular visits at CHUV, including swallowing and voice tests, questionnaires, and imaging exams. The study is expected to provide important information on how combining minimally invasive surgery with intensive rehabilitation can benefit patients' swallowing and overall quality of life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients scheduled for a surgery with robotic-assisted extended "Sistrunk" approach - multiport (RESA) with the Da Vinci Xi or SP robotic system for:
✓. Indication for speech, swallowing and voice rehabilitation after surgery
✓. Informed consent signature
✓. 18 years old or older at the time of informed consent signature
Exclusion criteria
✕. Inability to give informed consent
✕. Inability to follow study procedures (FEES, VFSS, questionnaires, "intensive" SSVR or else)
✕. Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule,
✕. Inability to memorize one analytic and one compensatory exercise at screening visit
✕. Participation in another study with an investigational drug or medical device within the 30 days preceding and during the present investigation,
What they're measuring
1
Swallowing function measured by composite MDADI score