Trial Outcomes & Findings for Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy (NCT NCT02768753)

Last Updated: 2019-09-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.

Results posted on

2019-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	The Axillary Bilateral-breast Approach (ABBA) Group 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	The Bilateral Axillo-breast Approach (BABA) Group 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 bilateral Axillo-breast Approach
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Axillary Bilateral-breast Approach (ABBA) Group n=30 Participants 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	The Bilateral Axillo-breast Approach (BABA) Group n=30 Participants 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 bilateral Axillo-breast Approach	Total n=60 Participants Total of all reporting groups
Age, Continuous	44.30 years STANDARD_DEVIATION 10.95 • n=5 Participants	38.20 years STANDARD_DEVIATION 9.82 • n=7 Participants	41.25 years STANDARD_DEVIATION 10.77 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index（BMI）	22.92 kg / m ^ 2 STANDARD_DEVIATION 3.54 • n=5 Participants	23.64 kg / m ^ 2 STANDARD_DEVIATION 3.21 • n=7 Participants	23.28 kg / m ^ 2 STANDARD_DEVIATION 3.37 • n=5 Participants

PRIMARY outcome

Timeframe: The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.

Outcome measures

Outcome measures
Measure	The Axillary Bilateral-breast Approach (ABBA) Group n=30 Participants 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	The Bilateral Axillo-breast Approach (BABA) Group n=30 Participants 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 bilateral Axillo-breast Approach
Change of VAS Pain Scores for the First 24 Hours	2.13 score Standard Deviation 1.10	2.33 score Standard Deviation 1.34

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Axillary Bilateral-breast Approach (ABBA) Group n=30 Participants 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	The Bilateral Axillo-breast Approach (BABA) Group n=30 Participants 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 bilateral Axillo-breast Approach
Cosmetic Outcomes	3.17 score Standard Deviation 0.93	3.90 score Standard Deviation 0.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Axillary Bilateral-breast Approach (ABBA) Group n=30 Participants 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	The Bilateral Axillo-breast Approach (BABA) Group n=30 Participants 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 bilateral Axillo-breast Approach
Subjective Voice	10.27 score Standard Deviation 3.77	10.70 score Standard Deviation 2.69

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	The Axillary Bilateral-breast Approach (ABBA) Group n=30 Participants 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	The Bilateral Axillo-breast Approach (BABA) Group n=30 Participants 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 bilateral Axillo-breast Approach
Swallowing Evaluation	1.23 score Standard Deviation 0.43	1.27 score Standard Deviation 0.45

Adverse Events

The Axillary Bilateral-breast Approach (ABBA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Bilateral Axillo-breast Approach (BABA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Qing Qing He，Dr.Gao Feng Ni

General Hospital of Jinan Military Area

Phone: 15653853675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place