Head and neck disease
Conditions
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 75 years (inclusive of 18 and 75 years);? 2) Male or female; 3) Patients who meet the indications for minimally invasive head and neck surgery and require transoral robotic surgery (TORS), including those diagnosed with benign tumors of the pharynx and larynx, as well as T1–T2 and selected T3 stage oropharyngeal, laryngeal, or hypopharyngeal carcinoma;? 4) Voluntarily agree to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with limited mouth opening;? 2) Patients with cervical lymph node metastases that are not amenable to surgical neck dissection;? 3) Patients who are unable to tolerate general anesthesia due to poor general condition;? 4) Patients with confluent lymph node metastases encasing major blood vessels;? 5) Patients with extensive tumor invasion into surrounding tissues who are not suitable candidates for minimally invasive surgery;? 6) Patients in poor general condition that cannot be corrected despite preoperative management;? 7) Patients with severe cardiac, pulmonary, hepatic, or renal disease who are unable to tolerate surgery;? 8) Patients requiring emergency surgery due to disease-related conditions;? 9) Patients with a history of continuous systemic corticosteroid or immunosuppressive therapy within the past one month;? 10) Patients who lack the mental capacity to consent or are unable to understand the requirements of study participation;? 11) Pregnant or breastfeeding women;? 12) Patients unwilling or unable to comply with medical instructions;? 13) Patients who have participated in another clinical trial within the past one month;? 14) Any other condition that, in the opinion of the investigator or medical staff, renders the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint evaluation;Complication;Adverse events/serious adverse events;Evaluation of equipment performance;Pain scores;Equipment defects;Vital signs (body temperature, breathing, pulse, blood pressure);Physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor biomarkers;Physical status score; | — |
Countries
China
Contacts
Public ContactLei Tao
Eye & ENT Hospital of Fudan University
Outcome results
None listed