Thyroidectomy, Thyroid Papillary Carcinoma
Conditions
Keywords
Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach
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.
Interventions
PROCEDUREThe Axillary Bilateral-breast Approach
PROCEDUREThe bilateral Axillo-breast Approach
Sponsors
Jinan Military General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | The Axillary Bilateral-breast Approach (ABBA) Group | The Bilateral Axillo-breast Approach (BABA) Group | Total |
|---|---|---|---|
| Age, Continuous | 44.30 years STANDARD_DEVIATION 10.95 | 38.20 years STANDARD_DEVIATION 9.82 | 41.25 years STANDARD_DEVIATION 10.77 |
| Body Mass Index（BMI） | 22.92 kg / m ^ 2 STANDARD_DEVIATION 3.54 | 23.64 kg / m ^ 2 STANDARD_DEVIATION 3.21 | 23.28 kg / m ^ 2 STANDARD_DEVIATION 3.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 30 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change of VAS Pain Scores for the First 24 Hours
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.
Time frame: The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) Group | Change of VAS Pain Scores for the First 24 Hours | 2.13 score | Standard Deviation 1.1 |
| The Bilateral Axillo-breast Approach (BABA) Group | Change of VAS Pain Scores for the First 24 Hours | 2.33 score | Standard Deviation 1.34 |
Primary
Cosmetic Outcomes
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.
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) Group | Cosmetic Outcomes | 3.17 score | Standard Deviation 0.93 |
| The Bilateral Axillo-breast Approach (BABA) Group | Cosmetic Outcomes | 3.90 score | Standard Deviation 0.31 |
Secondary
Subjective Voice
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.
Time frame: After operation 8 a.m. on the 7th day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) Group | Subjective Voice | 10.27 score | Standard Deviation 3.77 |
| The Bilateral Axillo-breast Approach (BABA) Group | Subjective Voice | 10.70 score | Standard Deviation 2.69 |
Secondary
Swallowing Evaluation
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
Time frame: 8 a.m. on the 3rd day after operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) Group | Swallowing Evaluation | 1.23 score | Standard Deviation 0.43 |
| The Bilateral Axillo-breast Approach (BABA) Group | Swallowing Evaluation | 1.27 score | Standard Deviation 0.45 |