Thyroid CancerNCT03577951
Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery
A study testing high position space group and low position space group in people with Thyroid Cancer and Endoscopy, run by Fujian Medical University at 1 site in China.
Trial summary
Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Endoscopy
- What is being tested?
- high position space group and low position space group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 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
- Patients with endoscopic thyroid surgery
- No previous neck surgery
Who cannot join
- Patients undergoing lateral neck lymph node dissection during the same period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
bo wang, md, 13705947900, wangbo@fjmu.edu.cn
About this study
Official title: Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery
Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.
Read the detailed description
Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.
- Conditions
- Thyroid Cancer, Endoscopy
- Being tested
- high position space group, low position space group
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high position space groupProcedure or surgery
The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
low position space groupProcedure or surgery
The left and right Trocar meet under the sternum angle and begin to establish the operating space.
| Study group | Role | What they receive |
|---|---|---|
| high position space group | Experimental | The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space. Receives: Procedure: high position space group |
| low position space group | Experimental | The left and right Trocar meet under the sternum angle and begin to establish the operating space. Receives: Procedure: low position space group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intercostal arterial bleeding
The number of intercostal artery bleeding
Measured: During surgery
Thyroidectomy time
Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)
Measured: During surgery
Secondary outcomes (3)
Thyroid volume
Thyroid volume calculated by preoperative ultrasound
Measured: Before surgery
Patient's BMI
BMI equals body weight divided by height squared
Measured: Before surgery
Assessment of skin sensory abnormalities
According to the visual scoring method, it was divided into 1-10 points and evaluated by the patient two months after surgery. The score of 10 points was the same as before surgery, and 0 points showed serious discomfort.
Measured: two months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Aug 2018
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT03577951
- Sponsor's protocol ID
- Space H and L
- Status last verified
- Sep 2018
- First submitted
- 24 Jun 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03577951
- Acronym / sponsor ID
- Space H and L
- Conditions
- Thyroid Cancer, Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 5 Jul 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.
Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.
Detailed description
Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high position space group | Experimental | Procedure: high position space groupThe left and right Trocar meet at the level of the sternum angle and begin to establish the operating space. |
| low position space group | Experimental | Procedure: low position space groupThe left and right Trocar meet under the sternum angle and begin to establish the operating space. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with endoscopic thyroid surgery
- No previous neck surgery
Key exclusion criteria (1 listed)
- Patients undergoing lateral neck lymph node dissection during the same period
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 |
|---|---|---|
| high position space groupThe left and right Trocar meet at the level of the sternum angle and begin to establish the operating space. | Procedure or surgery | high position space group |
| low position space groupThe left and right Trocar meet under the sternum angle and begin to establish the operating space. | Procedure or surgery | low position space group |
Primary outcome
Intercostal arterial bleeding
Time frame: During surgery
The number of intercostal artery bleeding
Thyroidectomy time
Time frame: During surgery
Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)
3 secondary outcomes
Thyroid volume
Time frame: Before surgery
Patient's BMI
Time frame: Before surgery
Assessment of skin sensory abnormalities
Time frame: two months after surgery
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.
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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 high position space group and low position space group in people with Thyroid Cancer and Endoscopy, 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 2 inclusion and 1 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intercostal arterial bleeding (time frame: During 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.