Back to resultsImpact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy (ET)
Primary Purpose
Thyroid Tumor
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Tumor focused on measuring thyroidectomy, invasiveness
Eligibility Criteria
Inclusion Criteria:
- thyroid nodule diagnosed by ultrasound
- willing to undergo endoscopic thyroidectomy
Exclusion Criteria:
- conversion to open surgery
- unwilling to join the research
Sites / Locations
- Department of General Surgery, Changzheng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
standard
limited dissection
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
post-operative pain
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
Secondary Outcome Measures
number of patients with adverse effect
record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)
Full Information
NCT ID
NCT01338597
First Posted
April 11, 2011
Last Updated
April 18, 2011
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01338597
Brief Title
Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
Acronym
ET
Official Title
Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Second Military Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Tumor
Keywords
thyroidectomy, invasiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard
Arm Type
Experimental
Arm Description
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.
Arm Title
limited dissection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
endoscopic thyroidectomy
Other Intervention Name(s)
limited flap dissection endoscopic thyroidectomy
Intervention Description
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
Primary Outcome Measure Information:
Title
post-operative pain
Description
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
Time Frame
24h post-operation
Secondary Outcome Measure Information:
Title
number of patients with adverse effect
Description
record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)
Time Frame
within 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
thyroid nodule diagnosed by ultrasound
willing to undergo endoscopic thyroidectomy
Exclusion Criteria:
conversion to open surgery
unwilling to join the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei zhang, MD
Phone
-8621-81885802
Email
zhangwei412@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
ming qiu, MD
Phone
8621-81885801
Email
qiuming2006@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ming qiu, MD
Organizational Affiliation
Changzheng Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General Surgery, Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei zhang, MD
Phone
8621-81885802
Email
zhangwei412@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
ming qiu, MD
Phone
8621-81885801
Email
qiuming2006@yahoo.cn
First Name & Middle Initial & Last Name & Degree
cheng-xiang shan, MD
First Name & Middle Initial & Last Name & Degree
sheng liu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19361288
Citation
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.
Results Reference
result
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Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
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