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

April 26, 2025 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Comparative Analysis of the Safety and Efficacy of Transoral Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Thyroid cancer patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Postoperative pathology was benign
  • Clinical data are incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Effectiveness of different surgical modalities in the treatment of thyroid cancer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key Observational Indicators
Time Frame: 6moths
Incidental parathyroidectomy rate
6moths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary observations
Time Frame: 6months
Incidence of hypoparathyroidism
6months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Pre-Specified Outcome
Time Frame: 6moths
Number of lymph nodes cleared
6moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.357[2024]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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