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

Thyroidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768753
• Other study ID #: ShandongJJZY-01
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: September 2019
• Source: Jinan Military General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer, Papillary
• Thyroid Papillary Carcinoma
• Thyroidectomy

Intervention

Procedure:
• The Axillary Bilateral-breast Approach

• The bilateral Axillo-breast Approach

Locations

Country	Name	City	State
China	Department of thyroid and breast surgery, General Hospital of Jinan Military Area	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jinan Military General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.
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.	3 months after surgery
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.	After operation 8 a.m. on the 7th day
Secondary	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	8 a.m. on the 3rd day after operation