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

NCT ID: NCT02768753

Last Updated: 2019-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Thyroid Papillary Carcinoma Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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The Axillary Bilateral-breast Approach (ABBA) group

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.

Group Type EXPERIMENTAL

The Axillary Bilateral-breast Approach

Intervention Type PROCEDURE

The bilateral Axillo-breast Approach (BABA) group

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.

Group Type EXPERIMENTAL

The bilateral Axillo-breast Approach

Intervention Type PROCEDURE

Interventions

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The Axillary Bilateral-breast Approach

Intervention Type PROCEDURE

The bilateral Axillo-breast Approach

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinan Military General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gaofeng Ni

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Jinan, Shandong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ShandongJJZY-01

Identifier Type: -

Identifier Source: org_study_id

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