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NCT Number: NCT02768753

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

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.

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Key information

Conditions

Thyroid Papillary Carcinoma Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms Thyroidectomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jinan, Shandong, 250000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Axillary Bilateral-breast Approach

Procedure

The bilateral Axillo-breast Approach

Procedure

Primary outcomes

  1. Change of VAS Pain Scores for the First 24 Hours

    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.

    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.

  2. Cosmetic Outcomes

    Time frame: 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 outcomes

  1. Subjective Voice

    Time frame: 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.

  2. Swallowing Evaluation

    Time frame: 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.

    • 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

Sponsors and collaborators

Lead sponsor

Jinan Military General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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