Thyroid Papillary CarcinomaNCT02768753
Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
A study testing The Axillary Bilateral-breast Approach and The bilateral Axillo-breast Approach in people with Thyroid Papillary Carcinoma and Thyroidectomy, run by Jinan Military General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Papillary Carcinoma, Thyroidectomy
- What is being tested?
- The Axillary Bilateral-breast Approach and The bilateral Axillo-breast Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of thyroid and breast surgery, General Hospital of Jinan Military Area
Jinan, Shandong, 250000
About this study
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.
Read the 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.
- Conditions
- Thyroid Papillary Carcinoma, Thyroidectomy
- Being tested
- The Axillary Bilateral-breast Approach, The bilateral Axillo-breast Approach
- Keywords
- Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Axillary Bilateral-breast ApproachProcedure or surgery
The bilateral Axillo-breast ApproachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) group | Experimental | 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. Receives: Procedure: The Axillary Bilateral-breast Approach |
| The bilateral Axillo-breast Approach (BABA) group | Experimental | 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. Receives: Procedure: The bilateral Axillo-breast Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VAS Pain Scores for the First 24 Hours
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.
Measured: 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
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.
Measured: 3 months after surgery
Secondary outcomes (2)
Subjective Voice
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.
Measured: After operation 8 a.m. on the 7th day
Swallowing Evaluation
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
Measured: 8 a.m. on the 3rd day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid Papillary CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan Military General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaofeng Ni, Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768753
- Sponsor's protocol ID
- ShandongJJZY-01
- Status last verified
- Sep 2019
- First submitted
- 2 May 2016
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
- ClinicalTrials.gov ID
- NCT02768753
- Acronym / sponsor ID
- ShandongJJZY-01
- Conditions
- Thyroid Papillary Carcinoma, Thyroidectomy
- Keywords
- Robotic thyroidectomy, Robotic central neck dissection, Axillary bilateral-breast approach, Bilateral axillo-breast approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jinan Military General HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 27 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Axillary Bilateral-breast Approach (ABBA) group | Experimental | Procedure: The Axillary Bilateral-breast ApproachAll 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. |
| The bilateral Axillo-breast Approach (BABA) group | Experimental | Procedure: The bilateral Axillo-breast ApproachAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Axillary Bilateral-breast Approach | Procedure or surgery | The Axillary Bilateral-breast Approach (ABBA) group |
| The bilateral Axillo-breast Approach | Procedure or surgery | The bilateral Axillo-breast Approach (BABA) group |
Primary outcome
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.
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.
2 secondary outcomes
Subjective Voice
Time frame: After operation 8 a.m. on the 7th day
Swallowing Evaluation
Time frame: 8 a.m. on the 3rd day after operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Axillary Bilateral-breast Approach and The bilateral Axillo-breast Approach in people with Thyroid Papillary Carcinoma and Thyroidectomy, run by Jinan Military General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.