Thyroid TumorETNCT01338597
Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
A study testing endoscopic thyroidectomy in people with Thyroid Tumor, run by Second Military Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Thyroid Tumor
- What is being tested?
- endoscopic thyroidectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Jun 2012
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- thyroid nodule diagnosed by ultrasound
- willing to undergo endoscopic thyroidectomy
Who cannot join
- conversion to open surgery
- unwilling to join the research
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
wei zhang, MD, 8621-81885802, zhangwei412@yahoo.com.cn
ming qiu, MD, 8621-81885801, qiuming2006@yahoo.cn
About this study
Official title: Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy
The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.
Read the detailed description
To create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. Large subcutaneous area was considered a drawback of endoscopic thyroidectomy. The purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.
- Conditions
- Thyroid Tumor
- Being tested
- endoscopic thyroidectomy
- Keywords
- thyroidectomy, invasiveness
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic thyroidectomyProcedure or surgery
Also called limited flap dissection endoscopic thyroidectomy
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
| Study group | Role | What they receive |
|---|---|---|
| standard | Experimental | 3 trocars are needed. two in the circumareolar region and one in the parasternal region. the dissection area begins from the trocar site and extends to the neck. Receives: Procedure: endoscopic thyroidectomy |
| limited dissection | Experimental | the dissection is reduced by creating a long tunnel from the trocar site and the dissection area confined in the upper chest wall and in the neck. Receives: Procedure: endoscopic thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
Measured: 24h post-operation
Secondary outcomes (1)
number of patients with adverse effect
record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)
Measured: within 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 posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid TumorStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- ming qiu, MD, Study chair, Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338597
- Sponsor's protocol ID
- SMMU-2011-ET-1
- Acronym
- ET
- Status last verified
- Apr 2011
- First submitted
- 11 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang M, Zhang T, Mao Z, Dong F, Li J, Lu A, Hu W, Zang L, Jiang Y, Zheng M. Effect of endoscopic thyroidectomy via anterior chest wall approach on treatment of benign thyroid tumors. J Laparoendosc Adv Surg Tech A. 2009 Apr;19(2):149-52. doi: 10.1089/lap.2008.0296.
PubMed 19361288
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy
- ClinicalTrials.gov ID
- NCT01338597
- Acronym / sponsor ID
- ET / SMMU-2011-ET-1
- Conditions
- Thyroid Tumor
- Keywords
- thyroidectomy, invasiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 Apr 2011 (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 purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.
Detailed description
To create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. Large subcutaneous area was considered a drawback of endoscopic thyroidectomy. The purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard | Experimental | Procedure: endoscopic thyroidectomy3 trocars are needed. two in the circumareolar region and one in the parasternal region. the dissection area begins from the trocar site and extends to the neck. |
| limited dissection | Experimental | Procedure: endoscopic thyroidectomythe dissection is reduced by creating a long tunnel from the trocar site and the dissection area confined in the upper chest wall and in the neck. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- thyroid nodule diagnosed by ultrasound
- willing to undergo endoscopic thyroidectomy
Key exclusion criteria (2 listed)
- conversion to open surgery
- unwilling to join the research
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 |
|---|---|---|
| endoscopic thyroidectomyAlso: limited flap dissection endoscopic thyroidectomyendoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area. | Procedure or surgery | limited dissection, standard |
Primary outcome
post-operative pain
Time frame: 24h post-operation
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
1 secondary outcome
number of patients with adverse effect
Time frame: within 3 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 19 Apr 2011.
- Results publication: PubMed 19361288Wang M, Zhang T, Mao Z, Dong F, Li J, Lu A, Hu W, Zang L, Jiang Y, Zheng M. Effect of endoscopic thyroidectomy via anterior chest wall approach on treatment of benign thyroid tumors. J Laparoendosc Adv Surg Tech A. 2009 Apr;19(2):149-52. doi: 10.1089/lap.2008.0296.
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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 study chair
Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic thyroidectomy in people with Thyroid Tumor, 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 2 inclusion and 2 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 19 Apr 2011. 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 wei zhang, MD (-8621-81885802, zhangwei412@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: 24h post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338597, which also lists 1 linked publication.
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 19 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.