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

Jinan Military General Hospital

Status: Completed

Conditions: Thyroid Papillary Carcinoma; Thyroidectomy

Treatments: Procedure: The Axillary Bilateral-breast Approach; Procedure: The bilateral Axillo-breast Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02768753

ShandongJJZY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

The Axillary Bilateral-breast Approach (ABBA) group

Experimental group

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.

Treatment:

Procedure: The Axillary Bilateral-breast Approach

The bilateral Axillo-breast Approach (BABA) group

Experimental group

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.

Treatment:

Procedure: The bilateral Axillo-breast Approach