Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
Phase: NA
Conditions: Thyroid Papillary Carcinoma, Thyroidectomy
Sponsor: Jinan Military General Hospital

 
 
 
 
 
 
 
 
Study Protocol 
 Comparison Between the Axillary Bilateral-breast 
Approach (ABBA) and Bilateral Axillo-breast Approach 
(BABA) for Robotic Thyroidectomy 
 (NCT02768753)  
April 30,2017 
 
 
 
 
 
 
 
 

Objective 
To compare the therapeuic effcts between the axillary bilateral-breast 
approach (ABBA) and bilateral axillo-breast approach (BABA)  for robotic 
thyroidectom.To explore the efficacy, safety, cosmetic results and clinical value 
by the two approaches 
Criteria 
Inclusion Criteria：The initial surgery;preoperative needle aspiration biopsy 
of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph 
node metastasis;the tumor is confined to the thyroid membrane, not invading 
trachea and recurrent laryngeal nerve;intraoperative frozen section diagnosis 
of thyroid cancer;the patient informed consent.  
Exclusion Criteria ：High-frequency ultrasound preoperative tumor 
diameter greater than 1cm, or lateral neck lymph node metastasis in 
patients;there had been a history of thyroid surgery or neck radiation 
therapy;pregnant or lactating women;with severe Hashimoto's thyroiditis, 
thyroid volume greater than II°;coagulation disorders,hyperthyroidism or 
hypothyroidism patients;sternal goiter. 
Methods 
    All patients were dived into two groups randomly.According to the 
standard of surgey,the 60 patients who have been diagnosed with thyroid 
cancer are numbered.The random number is even assigned ABBA group( n = 
30) and the random number is odd assigned BABA (n = 30).All patients were 
operated on by the same surgical team through the da Vinci robotic surgical 
system use method of circular mobilization. After the operation, the number of 
resected lymph nodes, intraoperative blood loss, postoperative pain scores 
24h, catheterization time, the time of drainage, Swallowing Evaluation , 
Subjective Voice , operative time, postoperative hospital stay, cosmetic results 
satisfaction,recurrent laryngeal nerve injury and hypoparathyroidism and other 
related complications were compared between groups. The patients were 

followed up for 3~22 months. 
Data management and statistical analysis: 
    SPSS 22.0.0 software was used for statistics. The measurement data 
were used to describe the average number of standard deviation; the ratio / 
rate of counting data was calculated; the measured data between the two 
groups were compared with the paired t test; the rate of the two groups was 
compared with the chi square test. The difference was statistically significant in 
p<0.05.