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Multicenter Prospective, Open-label, Randomized Controlled Trial Comparing Robotic Total Thyroidectomy with Lateral Neck Lymph Node Dissection Versus Open Surgery

Multicenter Prospective, Open-label, Randomized Controlled Trial Comparing Robotic Total Thyroidectomy with Lateral Neck Lymph Node Dissection Versus Open Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092402
Enrollment
Unknown
Registered
2024-11-15
Start date
2024-11-19
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Differentiated thyroid cancer

Interventions

Group B:Open surgery
Group A:Robotic surgery

Sponsors

The First Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.?18 years old <= age <=75 years old; 2.? Differentiated thyroid cancer diagnosed after FNA; 3.? Lesion diameter <=40mm; 4.? Patients with thyroid cancer who require thyroidectomy and who have clear or suspected lymph node metastases in the side of the neck that require lateral neck dissection; 5.? Willing to provide blood test samples, patient imaging and postoperative pathological routine and other relevant medical records, willing to use test data for scientific research in clinical institutions; 6.? Signed informed consent, willing to cooperate with this study for clinical follow-up.

Exclusion criteria

Exclusion criteria: 1.A history of thyroid surgery or neck radiotherapy (allowed to include thyroidectomy with the exception of the central area or total resection with the central area after the recurrence of the unoperated area on the side); 2.? Thyroid tumors invade the trachea, esophagus, neck great blood vessels and other adjacent important structures or distant metastases and can not be resected; 3.? Cervical metastatic lymph node fusion, invasion of large blood vessels, or metastatic lymph node with a short diameter greater than 3cm; 4.? No cervical lymph node metastasis was found in postoperative pathology; 5.? Patients with coagulation dysfunction or dysfunction of important organs such as heart and lung that cannot tolerate general anesthesia; 6.? The patient also has other medical conditions that may affect follow-up and short-term survival; 7.? Any social/psychological problems in which the investigator has determined that the patient is not suitable for participation in the study;

Design outcomes

Primary

MeasureTime frame
Local recurrence rate 5 years after surgery;

Secondary

MeasureTime frame
Hypoparathyroidism;Thoroughness of tumor resection;Subjective evaluation of postoperative quality of life;Postoperative aesthetic evaluation;Postoperative evaluation of voice, swallowing and neck function;

Countries

China

Contacts

Public ContactYi Zhang

The First Affiliated Hospital of Army Medical University, PLA

zhangyi1489@sina.com+86 13983701489

Outcome results

None listed

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