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Prospective clinical trials to evaluate the safety and efficacy of Abdominal Endoscopic Surgery System assisted laparoscopic oral and maxillofacial surgery

Prospective clinical trials to evaluate the safety and efficacy of Abdominal Endoscopic Surgery System assisted laparoscopic oral and maxillofacial surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076776
Enrollment
Unknown
Registered
2023-10-18
Start date
2023-10-31
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Salivary gland tumors/parotid gland tumors

Interventions

Sponsors

West China Stomatology Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old (inclusive), male and female; 2. Patients with tumors requiring excision of parotid or submandibular glands; 3. Willing to cooperate with and complete the study follow-up and related examinations; 4. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from serious cardiovascular or circulatory diseases or other diseases that cannot tolerate surgery; 2. ALT, AST and UREA exceeded the upper limit of normal value by 1.5 times, and platelet count was = 4cm; 4. Women who are pregnant or breastfeeding, or women who have a pregnancy and birth plan during the study period; 5. Have a history of epilepsy or mental illness; 6. People with severe allergies, suspected or confirmed alcohol or drug addiction; 7. Inability to understand the study requirements or to complete the study follow-up plan; 8. General anesthesia is contraindicated; 9. Patients undergoing reoperation in the same operative area; 10. Malignant tumors requiring deep parotid gland lobectomy; 11. Serious adhesion between the gland and surrounding tissue during preoperative physical examination; 12. Patients with facial nerve palsy before surgery; 13. Participants in clinical trials of other investigational drugs or devices within 3 months; 14. Situations in which the researcher considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
No conversion rate;

Secondary

MeasureTime frame
Subject pain score;Operator satisfaction;Incidence of complications;Estimated intraoperative bleeding and transfusion volume;

Countries

China

Contacts

Public ContactGuiquan Zhu

West China Stomatology Hospital, Sichuan University

zhugq@scu.edu.cn+86 159 0289 1530

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026