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

Primary Purpose

Thyroid Papillary Carcinoma, Thyroidectomy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The Axillary Bilateral-breast Approach
The bilateral Axillo-breast Approach
Sponsored by
Jinan Military General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Papillary Carcinoma focused on measuring Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of thyroid and breast surgery, General Hospital of Jinan Military Area

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The Axillary Bilateral-breast Approach (ABBA) group

The bilateral Axillo-breast Approach (BABA) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Swallowing Evaluation
The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough. score (excellent) can swallow water smoothly once score (good) more than 2 times, can swallow without coughing score (middle) can swallow once, but have a choking cough score (may) more than 2 times swallowing, but with choking cough score (difference) frequent cough, not all swallowing Calculate the average value for statistical analysis

Full Information

First Posted
May 2, 2016
Last Updated
September 2, 2019
Sponsor
Jinan Military General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02768753
Brief Title
Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
Official Title
Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinan Military General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Papillary Carcinoma, Thyroidectomy
Keywords
Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Axillary Bilateral-breast Approach (ABBA) group
Arm Type
Experimental
Arm Description
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.
Arm Title
The bilateral Axillo-breast Approach (BABA) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The Axillary Bilateral-breast Approach
Intervention Type
Procedure
Intervention Name(s)
The bilateral Axillo-breast Approach
Primary Outcome Measure Information:
Title
Change of VAS Pain Scores for the First 24 Hours
Description
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.
Title
Cosmetic Outcomes
Description
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
Secondary Outcome Measure Information:
Title
Subjective Voice
Description
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
Title
Swallowing Evaluation
Description
The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough. score (excellent) can swallow water smoothly once score (good) more than 2 times, can swallow without coughing score (middle) can swallow once, but have a choking cough score (may) more than 2 times swallowing, but with choking cough 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of thyroid and breast surgery, General Hospital of Jinan Military Area
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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