Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy (ET)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Second Military Medical University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Second Military Medical University
Information provided by:
Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01338597
First received: April 11, 2011
Last updated: April 18, 2011
Last verified: April 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 11, 2011 | ||||||||
| Last Updated Date | April 18, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
post-operative pain [ Time Frame: 24h post-operation ] [ Designated as safety issue: No ] 24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01338597 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
number of patients with adverse effect [ Time Frame: within 3 months after surgery ] [ Designated as safety issue: Yes ] record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia) |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy | ||||||||
| Official Title ICMJE | Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy | ||||||||
| Brief Summary | The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Thyroid Tumor | ||||||||
| Intervention ICMJE | Procedure: endoscopic thyroidectomy
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
Other Name: limited flap dissection endoscopic thyroidectomy |
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| Study Arm (s) |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01338597 | ||||||||
| Other Study ID Numbers ICMJE | SMMU-2011-ET-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | department of general surgery, changzheng hospital | ||||||||
| Study Sponsor ICMJE | Second Military Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Second Military Medical University | ||||||||
| Verification Date | April 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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