Surgical Competency for Robot-Assisted Thyroidectomy: Construction and Validation of a Robotic Thyroidectomy Assessment Score (RTAS)

NCT06730321 | Recruiting

• 1 other identifier: 2024-KY-245(K)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To develop and validate a structured scoring tool (robotic thyroidectomy assessment score, RTAS) for assessing and quantifying surgical performance in robotic thyroidectomy (RT).

Conditions

Thyroid Cancer; Thyroid Nodule; Thyroid Diseases; Thyroid Cancer, Papillary; Thyroid Cancer, Follicular

Keywords

Robotic thyroidectomy; Surgical competency; Robotic thyroidectomy assessment score

Outcome Measures

Primary Outcomes (4)

• Number of participants with recurrent laryngeal nerve injury

  impaired vocal cord mobility confirmed by postoperative laryngoscopy

  through study completion, an average of 1 year

• Number of participants with hypoparathyroidism

  a postoperative parathyroid hormone level of less than 10 pg/ml

  through study completion, an average of 1 year

• Operative time

  operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet

  through study completion, an average of 1 year

• Score for surgical competence

  score evaluated by the proposed assessment system

  at the end of robotic thyroidectomy

Secondary Outcomes (2)

• hospitalization

  through study completion, an average of 1 year

• degree of pain

  approximately 4 hours after surgery and on postoperative day 1

Study Arms (1)

Patients underwent robotic thyroidectomy

Patients underwent robotic thyroidectomy without conversion during the study period

Other: Observations on clinicopathological factors influencing the assessment score of surgery

Interventions

Observations on clinicopathological factors influencing the assessment score of surgery OTHER

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Patients underwent robotic thyroidectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were well informed about the robotic thyroidectomy and were aware of the potential benefits and risks. Patients underwent robotic thyroidectomy during the study period. Patient consented for us to use perioperative data.

You may qualify if:

• Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
• Clinical diagnosis of benign thyroid nodules with a maximum diameter not exceeding 6 cm
• Participants with high cosmetic expectations
• Participants underwent robotic thyroidectomy without open conversion

You may not qualify if:

• Participants with history of neck surgery or radiation
• Participants with vocal fold fixation by preoperative fibrolaryngoscope
• Participants with preoperative examination suggestive of distant invasion
• Participants with fusion or fixed of lymph nodes in the neck

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Thyroid Diseases; Thyroid Cancer, Papillary; Thyroid cancer, follicular

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ling Zhan, Doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhan, Doctor

CONTACT

08615821120972; rebecca0428zhan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (1)