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A Prospective Randomized Controlled Multi-center Clinical Trial for Comparison of Sternocleidomastoid Muscle Approach and Linea Alba Cervicalis Approach in Thyroid Cancer Operation

A Prospective Randomized Controlled Multi-center Clinical Trial for Comparison of Sternocleidomastoid Muscle Approach and Linea Alba Cervicalis Approach in Thyroid Cancer Operation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093678
Enrollment
Unknown
Registered
2024-12-10
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Differentiated Thyroid Cancer

Interventions

linea alba cervicalis approach operation:The affected thyroid gland lobe and isthmus excised and ipsilateral central lymph node dissection via cervical alba approach
sternocleidomastoid muscle approach operation:The affected thyroid gland lobe and isthmus excised and ipsilateral central lymph node dissection via sternocleidomastoid muscle approach

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and <70 years; 2. Accept open thyroid surgery; 3. Preoperative judgment of single malignant thyroid tumor, diameter <= 1cm, confined to one side of the gland, no thyroid capsule or external gland invasion, no cervical lymph node metastasis indicated in imaging examination,and lobectomy+isthmectomy+central area cervical lymph node dissection of the affected side was planned; 4.Willing to participate in the study, comply with the study requirements and follow-up arrangements, and sign the ICF; 5. The researchers believe that the expected postoperative survival time of the subjects is not less than 12 months; 6. BMI<30 kg/m^2; 7. Preoperative ECOG(Eastern Cooperative Oncology Group)0/1; 8. Preoperative ASA(American Society of Anesthesiologists)I-III.

Exclusion criteria

Exclusion criteria: 1. Women in pregnancy or lactation at the time of screening; 2. Preoperative judgment of thyroid malignant tumor >1cm, or invasion of thyroid capsule or external gland, or lateral cervical lymph node metastasis; 3. Multiple thyroid malignant tumors or located in bilateral glands; 4. Thyroid isthmus tumor; 5. Suspected or confirmed medullary or undifferentiated thyroid carcinoma; 6. Have peripheral vascular diseases that affect blood supply of neck; 7. Active infectious collagen disease (such as scleroderma) or any other disease that may interfere with wound healing; 8. Diagnosed with diabetes; 9. History of coagulation dysfunction; 10. Being treated with oral or intravenous antibiotics for a pre-existing disease or infection; 11. Serious mental illness; 12. serious respiratory illness; 13. Severe cardiopulmonary insufficiency; 14. Severe hepatic and renal insufficiency; 15. History of unstable angina pectoris or myocardial infarction within 6 months; 16. History of cerebral infarction or cerebral hemorrhage within 6 months; 17. History of use of immunosuppressive drugs (such as steroids) within 6 months prior to enrollment; 18. Received chemotherapy or radiotherapy within 6 months prior to study enrollment, or was scheduled to receive chemotherapy or radiotherapy during the study period; 19. A personal or family history of keloid formation; 20. Currently participating in clinical studies of any other drug (within 30 days or within five half-lives of the experimental drug) or devices; 21. Surgical treatment for other diseases or emergency thyroid surgery is required at the same time; 22. Previous thyroid surgery history, excluding thyroid fine needle aspiration cytology; 23. Patients with hoarseness, vocal cord fixation and other nerve compression or injury before surgery; 24. Grade III goiter; 25. Renal impairment and hyperparathyroidism were observed before study enrollment; 26. For any other reason judged by the researcher as not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
operative complication rate;

Secondary

MeasureTime frame
Evaluation of incision appearance;Postoperative Quality of Life;

Countries

China

Contacts

Public ContactWu Yijun

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

wu1jun@qq.com+86 13989815925

Outcome results

None listed

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