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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) group | Experimental | 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. |
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| The bilateral Axillo-breast Approach (BABA) group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Axillary Bilateral-breast Approach | Procedure |
| ||
| The bilateral Axillo-breast Approach |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded. |
| 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. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After operation 8 a.m. on the 7th day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of thyroid and breast surgery, General Hospital of Jinan Military Area | Jinan | Shandong | 250000 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2017 | Sep 2, 2019 |
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| Procedure |
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| Swallowing Evaluation | The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough.
| 8 a.m. on the 3rd day after operation |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index（BMI） | units:kg / m ^ 2 Mean(Standard Deviation) | Mean | Standard Deviation | kg / m ^ 2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score | The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded. |
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| 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. | Posted | Mean | Standard Deviation | score | 3 months after surgery |
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| 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. | Posted | Mean | Standard Deviation | score | After operation 8 a.m. on the 7th day |
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| Secondary | Swallowing Evaluation | The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough.
| Posted | Mean | Standard Deviation | score | 8 a.m. on the 3rd day after operation |
|
From the beginning of the operation to 1 years after the operation
First of all, our operation team has a very rich experience in thyroid surgery(More than 120 cases of thyroid surgery by Da VinciSi have been successfully implemented). Secondly, we are using the Da VinciSi strictly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Qing Qing He，Dr.Gao Feng Ni | General Hospital of Jinan Military Area | 15653853675 | m15653853675@163.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2017 | Sep 2, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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