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

September 2, 2019 updated by: Gaofeng Ni, Jinan Military General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Department of thyroid and breast surgery, General Hospital of Jinan Military Area

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: The Axillary Bilateral-breast Approach
Experimental: 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.
Procedure: The bilateral Axillo-breast Approach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.
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.
3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
After operation 8 a.m. on the 7th day
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.

  1. score (excellent) can swallow water smoothly once
  2. score (good) more than 2 times, can swallow without coughing
  3. score (middle) can swallow once, but have a choking cough
  4. score (may) more than 2 times swallowing, but with choking cough
  5. score (difference) frequent cough, not all swallowing Calculate the average value for statistical analysis
8 a.m. on the 3rd day after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinan Military General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShandongJJZY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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