Tumors requiring superficial lobe resection of the parotid gland
Conditions
Interventions
Sponsors
West China Stomatology Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old (inclusive), male or female not limited; 2. Tumor patients requiring superficial parotid lobectomy; 3. Willing to cooperate and complete research follow-up and related examinations; 4. Those who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from severe cardiovascular or circulatory system diseases or other intolerable surgical conditions; 2. During the screening period, ALT, AST, and UREA exceeded the upper limit of normal values by 1.5 times, and platelet count was less than 80 × 109/L; 3. Tumor length >= 4cm; 4. Pregnant or lactating women, or women with pregnancy and childbirth plans during the study period; 5. History of epilepsy or mental illness; 6. Severe allergic constitution, suspected or diagnosed alcohol or drug addicts; 7. Unable to understand the research requirements or unable to complete the research follow-up plan; 8. General anesthesia is contraindicated; 9. Patients undergoing reoperation in the same surgical area; 10. Patients with severe adhesion between the gland and surrounding tissues during preoperative physical examination; 11. Patients who already have facial nerve paralysis before surgery; 12. Participants in clinical trials of other investigational drugs or devices within three months; 13. The researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Untransmission rate during surgery;Incidence of complications related or potentially related to the device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject pain score;Overall incidence of surgical complications;operative time;Intraoperative bleeding and blood transfusion volume;Laboratory Examination;hospital stay;Equipment defect incidence rate;Incidence of adverse events and serious adverse events;Surgical satisfaction; | — |
Countries
China
Contacts
Public ContactChunjie Li
West China Stomatology Hospital, Sichuan University
Outcome results
None listed