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A Randomized Controlled Study for Safety Assessment of Ambulatory Endoscopic Thyroidectomy via Chest-Breast Approach

A Randomized Controlled Study for Safety Assessment of Ambulatory Endoscopic Thyroidectomy via Chest-Breast Approach

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041751
Enrollment
Unknown
Registered
2021-01-04
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Thyroid nodule

Interventions

Conventional Group:receive endoscopic thyroidectomy via chest-breast approach in a conventional management
Ambulatory Group:receive endoscopic thyroidectomy via chest-breast approach in an ambulatory management

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects of any gender. 2. The subjects were older than 18 years old. 3. Before the operation, the subjects are willing and able to sign the informed consent approved by the institutional review board (IRB), ethics committee (EC) or ethics review board (ERB). 4. According to the judgment of clinical researchers, the subjects can understand the clinical study and cooperate with the research process. 5. No previous history of neck surgery. 6. Patients with thyroid nodules (the largest diameter is less than 4cm) have indications for surgery, cosmetic needs and willingness to accept endoscopic surgery. 7. The subjects who had no cervical lymph node metastasis (cN0) before operation had no distant metastasis.

Exclusion criteria

Exclusion criteria: 1. Subjects who can not provide written consent for voluntary participation in clinical research. 2. Patients with chronic diseases, severe liver and kidney insufficiency, acute infectious diseases, autoimmune diseases, malignant tumors and other diseases. 3. Subjects with alcohol or drug addiction and / or mental illness, and the researchers think that it may affect their participation in this study. 4. Patients with diseases that restrict their participation in this study can not comply with the follow-up requirements or affect the scientific integrity of the study. 5. Subjects who are currently participating in another trial drug or device study. 6. Subjects with preoperative local invasion such as trachea, esophagus, recurrent laryngeal nerve or neck vessels. 7. Due to cardiopulmonary insufficiency or any other reasons, daytime surgery is not allowed (ASA grade >= 3). 8. Patients with medullary thyroid carcinoma should be considered before operation; 9. Subjects with history of breast augmentation, neck radiation and obesity who are not suitable for transthoracic endoscopic thyroidectomy.

Design outcomes

Primary

MeasureTime frame
incidence of complications;readmission rate within 30 days;

Secondary

MeasureTime frame
Hospitalization expenses;Hospitalization Days;

Countries

China

Contacts

Public ContactXinying Li

Xiangya Hospital, Zhongnan University

lixinyingcn@126.com+86 13755110832

Outcome results

None listed

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