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

J

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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