Laryngeal cancer
Conditions
Interventions
only one group of case, no control group:3 patients conducting total laryngectomy with primary puncture of VP device.
Sponsors
Department of Otolaryngology Head and Neck Surgery, Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants in this clinical trial must meet all of the following criteria: 1) Age greater than 18 years old; Gender unlimited; 2) Late stage laryngeal or hypopharyngeal cancer requires total laryngectomy; 3) Capable of self-care both mentally and physically, with good hand coordination skills; 4) Having a healthy tracheoesophageal common wall; 5) Patients have a desire to recover their pronunciation function after surgery and have the financial ability to bear the demand for product replacement after the clinical trial ends on their own; 6) Able to speak Mandarin and have a certain level of reading ability (equivalent to primary school education level) before surgery; 7) The subjects fully understand the benefits and risks of this trial, and are willing to participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Participants in this clinical trial must not meet any of the following criteria: 1) Serious respiratory system diseases or defects exist; 2) Obvious intellectual and mental disorders; 3) Individuals with restricted speech and other subjects with difficulty in articulation or language disorders (such as sequelae of cerebral infarction); 4) Severe respiratory system diseases, patients with cardiovascular and pulmonary diseases (such as severe arrhythmia, slow ventricular rate (ventricular rate1.5 times the upper normal limit), sepsis, and other unsuitable individuals; 5) Patients with severe liver and kidney function disorders (liver function indicators such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>twice the upper normal limit); Renal function indicators such as urinary creatinine (UCr) and blood urea nitrogen (BUN) are greater than twice the upper normal limit; 6) Patients with local recurrence or metastatic tumors; 7) Women during the entire clinical study period, including family planning, lactation, and pregnancy; 8) Participated in other clinical trials within one month; 9) Other researchers believe that it is not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Voice assessment;Acoustic analysis of voice; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complications;Voice handicap index, VHI; | — |
Countries
China
Contacts
Public ContactChunping Wu
Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Outcome results
None listed