Safety and Efficacy of Transoral Robotic Thyroidectomy Versus Traditional Open Thyroidectomy for Thyroid Cancer

NCT06958601 | Not Yet Recruiting DMC

• 1 other identifier: No.357[2024]
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

In general, the utilization of the transoral vestibular approach in robotic surgery demonstrates efficacy comparable to that of traditional open surgery in the treatment of thyroid cancer. This method not only reduces the length of hospitalization for patients but also ensures superior cosmetic outcomes in the cervical region, thus achieving truly scarless aesthetics. The feasibility of Transoral Vestibular Robotic Thyroidectomy (TOVRT) for tumors greater than 2 cm in diameter warrants further exploration in future studies; however, for tumors less than 2 cm in diameter, TOVRT emerges as a safe, reliable, and practical alternative, poised to establish itself as an innovative surgical modality.

Conditions

Thyroid Cancers

Outcome Measures

Primary Outcomes (1)

• Key Observational Indicators

  Incidental parathyroidectomy rate

  6moths

Secondary Outcomes (1)

• Secondary observations

  6months

Other Outcomes (1)

• Other Pre-Specified Outcome

  6moths

Study Arms (2)

traditional open group

1\) General demographic information: including age, gender, ethnicity, etc. 2) Disease-related information: lesion size, lesion location, pathological type, parathyroid function (preoperative, first day postoperative, and one week postoperative), thyroid function (preoperative and one month postoperative), etc.3) Surgery-related information: occurrence of postoperative complications, total number of days of hospitalization following the operation, postoperative quality of life (dysphagia index, neck injury index), etc.

Other: surgical procedure

robotic group

1\) General demographic information: including age, gender, ethnicity, etc. 2) Disease-related information: lesion size, lesion location, pathological type, parathyroid function (preoperative, first day postoperative, and one week postoperative), thyroid function (preoperative and one month postoperative), etc.3) Surgery-related information: occurrence of postoperative complications, total number of days of hospitalization following the operation, postoperative quality of life (dysphagia index, neck injury index), etc.

Interventions

surgical procedure OTHER

Effectiveness of different surgical modalities in the treatment of thyroid cancer

traditional open group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thyroid cancer patients

You may qualify if:

• Age 18- 65 years old, both male and female
• Postoperative pathology was papillary thyroid carcinoma
• Clinical data integrity

You may not qualify if:

• Postoperative pathology was benign
• Clinical data are incomplete

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Yan Xu

CONTACT

15923100038; xy931@163.com

Fu Luo

CONTACT

15121528940; luofu@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share