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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025980
Enrollment
Unknown
Registered
2019-09-16
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Thyroid Cancer

Interventions

Experimental Group:sternocleidomastoid muscle approach operation
Control Group:linea alba cervicalis approach operation

Sponsors

The First Affiliated Hospital of Zhejiang University, School of Medicine
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. Willing to participate in the study, comply with the study requirements and follow-up arrangements, and sign the ICF; 4. Agreed not to accept any selective operation other than this study arranged operation until study completed; 5. The researchers believe that the expected postoperative survival time of the subjects is not less than 3 months; 6. 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.

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 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. Fasting blood glucose (FPG) >= 7.7mmol /L; 9. History of coagulation dysfunction; 10. Being treated with oral or intravenous antibiotics for a pre-existing disease or infection; 11. History of use of immunosuppressive drugs (such as steroids) within 6 months prior to enrollment; 12. Received chemotherapy or radiotherapy within 6 months prior to study enrollment, or was scheduled to receive chemotherapy or radiotherapy during the study period; 13. A personal or family history of keloid formation; 14. Currently participating in clinical studies of any other drug (within 30 days or within five half-lives of the experimental drug) or devices; 15. Previous thyroid surgery history, excluding thyroid fine needle aspiration cytology; 16. Patients with hoarseness, vocal cord fixation and other nerve compression or injury before surgery; 17. Grade III goiter; 18. Renal impairment and hyperparathyroidism were observed before study enrollment; 19. 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
Postoperative Grade A wound healing rate;postoperative surgical site infection rate;Postoperative VAS score;Evaluation of incision appearance;Degree of postoperative neck discomfort symptoms;

Countries

China

Contacts

Public ContactWu Yijun

The First Affiliated Hospital of Zhejiang University, School of Medicine

wuwu5925@zju.edu.cn+86 571-87236855

Outcome results

None listed

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