Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy

Not Applicable

Completed

• Conditions: Thyroid Papillary Carcinoma; Thyroidectomy
• Interventions: Procedure: The bilateral Axillo-breast Approach; Procedure: The Axillary Bilateral-breast Approach

• Registration Number: NCT02768753
• Lead Sponsor: Jinan Military General Hospital

Brief Summary

The purpose of this study is to compare the therapeutic effects between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two approaches.

Detailed Description

Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy have been described. The investigators therefore designed a prospective trial comparing outcomes, including surgical outcomes and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Results First Submitted: 2017-04-22
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-02
• Last Update Submitted: 2019-09-02
• Results First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. the initial surgery
2. preoperative needle aspiration biopsy of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph node metastasis
3. the tumor is confined to the thyroid membrane, not invading trachea and recurrent laryngeal nerve
4. intraoperative frozen section diagnosis of thyroid cancer
5. the patient informed consent.

Exclusion Criteria

1. high-frequency ultrasound preoperative tumor diameter greater than 1cm, or lateral neck lymph node metastasis in patients
2. there had been a history of thyroid surgery or neck radiation therapy
3. pregnant or lactating women
4. with severe Hashimoto's thyroiditis, thyroid volume greater than II °
5. coagulation disorders, hyperthyroidism or hypothyroidism patients
6. sternal goiter.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The bilateral Axillo-breast Approach (BABA) group	The bilateral Axillo-breast Approach	All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.
The Axillary Bilateral-breast Approach (ABBA) group	The Axillary Bilateral-breast Approach	All patients were told about the operative techniques involved in robotic thyroidectomy via the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA), and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.

Primary Outcome Measures

Name	Time	Method
Change of VAS Pain Scores for the First 24 Hours	The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.	The visual analogue scale is utilized to assess the postoperative pain change for the first 24 hours.Using a 10cm straight line, one end is marked 0 for "pain free" and the other end is marked 10 for "unbearable pain". The pain intensity of the patient's own feelings was marked on a straight line, and the length from 0 to the marked point represented the pain level of the patient. The evaluation criteria of VAS were as follows: 0 for pain, 3 for mild pain, 4 to 6 for moderate pain and 7 to 10 for severe pain.Lower values represent better outcomes, higher values represent worse outcomes.
Cosmetic Outcomes	3 months after surgery	The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 3 months after the operation.

Secondary Outcome Measures

Name	Time	Method
Subjective Voice	After operation 8 a.m. on the 7th day	We have developed a questionnaire with a total of 30 questions, each with a score of 4, and the patients scored according to their own situation. The highest score of the questionnaire is 120, the lowest score is 0, the best, the score is 0-30, 30-60 is good, 60-90 is normal, 90-120 is poor.
Swallowing Evaluation	8 a.m. on the 3rd day after operation	The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough.; 1. score (excellent) can swallow water smoothly once; 2. score (good) more than 2 times, can swallow without coughing; 3. score (middle) can swallow once, but have a choking cough; 4. score (may) more than 2 times swallowing, but with choking cough; 5. score (difference) frequent cough, not all swallowing Calculate the average value for statistical analysis

Trial Locations

Locations (1)

Department of thyroid and breast surgery, General Hospital of Jinan Military Area; 🇨🇳 Jinan, Shandong, China