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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai 6th People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observations on clinicopathological factors influencing the assessment score of surgery

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients underwent robotic thyroidectomy1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with recurrent laryngeal nerve injury

impaired vocal cord mobility confirmed by postoperative laryngoscopy

Time frame
through study completion, an average of 1 year
2

Number of participants with hypoparathyroidism

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

Time frame
through study completion, an average of 1 year
3

Operative time

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

Time frame
through study completion, an average of 1 year
4

Score for surgical competence

score evaluated by the proposed assessment system

Time frame
at the end of robotic thyroidectomy

Secondary outcomes

1

hospitalization

days of hospitalization

Time frame
through study completion, an average of 1 year
2

degree of pain

pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain

Time frame
approximately 4 hours after surgery and on postoperative day 1

Other outcomes

Sponsors and contacts

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