EndoscopyNCT03454477
Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy
A study testing conventional open surgery, endoscopic thyroidectomy and robotic thyroidectomy in people with Endoscopy and Robotics, run by Fujian Medical University at 1 site in China.
Trial summary
Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endoscopy, Robotics, Thyroidectomy
- What is being tested?
- conventional open surgery, endoscopic thyroidectomy and robotic thyroidectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Thyroid papillary carcinoma.
- The tumor diameter is less than or equal to 1cm.
- The lymph nodes are limited to the VI level.
- Voluntary choice of endoscopy or robotic surgery.
Who cannot join
- Patients without beauty needs.
- There is lateral neck or mediastinal lymph node metastasis.
- The tumor invades the nerve and surrounding organs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wen-xin ZHAO
Fuzhou, Fujian, 350001
Wen-xin ZHAO, MD, 8613365910359, zhaowx@fjmu.edu.cn
Bo WANG, MD, 8613705947900, wangbo@fjmu.edu.cn
About this study
Official title: From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.
Read the detailed description
With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.
- Conditions
- Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
- Being tested
- conventional open surgery, endoscopic thyroidectomy, robotic thyroidectomy
- Keywords
- Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
- 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.
conventional open surgeryProcedure or surgery
conventional open surgery
endoscopic thyroidectomyProcedure or surgery
endoscopic thyroidectomy
robotic thyroidectomyDevice
robotic thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| conventional open surgery | Experimental | Patients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery. Receives: Procedure: conventional open surgery |
| endoscopic thyroidectomy | Experimental | Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy Receives: Procedure: endoscopic thyroidectomy |
| robotic thyroidectomy | Experimental | Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery. Receives: Device: robotic thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
Assess the operation time
Measured: The first day after surgery
recurrent laryngeal nerve palsy
the number of recurrent laryngeal nerve palsy
Measured: 2 months post operation
Secondary outcomes (2)
thyroid volume
thyroid volume
Measured: The day before the operation
cosmetic effect
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 2 months after the operation.
Measured: 2 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Feb 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454477
- Sponsor's protocol ID
- Robotic thyroidectomy
- Status last verified
- Sep 2018
- First submitted
- 7 Feb 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
- ClinicalTrials.gov ID
- NCT03454477
- Acronym / sponsor ID
- Robotic thyroidectomy
- Conditions
- Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
- Keywords
- Endoscopy, Robotics, Thyroidectomy, Papillary Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.
Detailed description
With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional open surgery | Experimental | Procedure: conventional open surgeryPatients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery. |
| endoscopic thyroidectomy | Experimental | Procedure: endoscopic thyroidectomyPatients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy |
| robotic thyroidectomy | Experimental | Device: robotic thyroidectomyPatients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thyroid papillary carcinoma.
- The tumor diameter is less than or equal to 1cm.
- The lymph nodes are limited to the VI level.
- Voluntary choice of endoscopy or robotic surgery.
Key exclusion criteria (3 listed)
- Patients without beauty needs.
- There is lateral neck or mediastinal lymph node metastasis.
- The tumor invades the nerve and surrounding organs.
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 |
|---|---|---|
| conventional open surgeryconventional open surgery | Procedure or surgery | conventional open surgery |
| endoscopic thyroidectomyendoscopic thyroidectomy | Procedure or surgery | endoscopic thyroidectomy |
| robotic thyroidectomyrobotic thyroidectomy | Device | robotic thyroidectomy |
Primary outcome
operation time
Time frame: The first day after surgery
Assess the operation time
recurrent laryngeal nerve palsy
Time frame: 2 months post operation
the number of recurrent laryngeal nerve palsy
2 secondary outcomes
thyroid volume
Time frame: The day before the operation
cosmetic effect
Time frame: 2 months post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional open surgery, endoscopic thyroidectomy and robotic thyroidectomy in people with Endoscopy and Robotics, run by Fujian Medical University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bo wang, md (13705947900, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: The first day after surgery). 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 18 Sep 2018.