Thyroid NoduleNCT00877630
Minimal Invasiveness of Endoscopic Thyroidectomy
An observational study of Thyroid Nodule, run by Second Military Medical University at 1 site in China.
Trial summary
The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodule
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Sep 2006to May 2007
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted in the ward who are diagnosed with thyroid nodule and will undergo thyroidectomy
Who may be able to join
- thyroidectomy nodule diagnosed by ultrasound
Who cannot join
- thyroid carcinoma
Trial locations and contacts
1 site in 1 country.
China1 site
Minimally Invasive Surgical Center of Changzhang Hospital
Shanghai, 200003
About this study
The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.
- Conditions
- Thyroid Nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1:endoscopic group | patients underwent endoscopic thyroidectomy | |
| 2:conventional group | patients underwent open thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IL-6 and CRP levels before and after operation
Measured: 0, 2, 12, 24, 48 hours after surgery
Visual Analogue Scale (VAS) score
Measured: 2, 12, 24, 48 hours after surgery
Cosmetic outcomes after surgery
Measured: 3 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 posted8 Apr 2009 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Ming Qiu, MD., Ph D, Study director, SMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877630
- Sponsor's protocol ID
- SMMU-2-2009-2
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 10 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasiveness of Endoscopic Thyroidectomy
- ClinicalTrials.gov ID
- NCT00877630
- Acronym / sponsor ID
- SMMU-2-2009-2
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Apr 2009 (estimated)
- 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.
The investigators had performed more than 250 cases of breast approach endoscopic thyroidectomy (BAET). The goal of this study is to evaluate whether BAET could be a minimally invasive procedure under the expert's hands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:endoscopic group | – | –patients underwent endoscopic thyroidectomy |
| 2:conventional group | – | –patients underwent open thyroidectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted in the ward who are diagnosed with thyroid nodule and will undergo thyroidectomy
Key inclusion criteria (1 listed)
- thyroidectomy nodule diagnosed by ultrasound
Key exclusion criteria (1 listed)
- thyroid carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum IL-6 and CRP levels before and after operation
Time frame: 0, 2, 12, 24, 48 hours after surgery
Visual Analogue Scale (VAS) score
Time frame: 2, 12, 24, 48 hours after surgery
Cosmetic outcomes after surgery
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
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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.
Ming Qiu, MD., Ph D study director
SMMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Second Military 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 1 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: finished, as of the sponsor's last update on 10 Apr 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum IL-6 and CRP levels before and after operation (time frame: 0, 2, 12, 24, 48 hours after surgery). The study lists 3 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 10 Apr 2009.