Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
ET
Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 19, 2011
April 1, 2011
8 months
April 11, 2011
April 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative pain
24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)
24h post-operation
Secondary Outcomes (1)
number of patients with adverse effect
within 3 months after surgery
Study Arms (2)
standard
EXPERIMENTAL3 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
EXPERIMENTALthe 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.
Interventions
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
Eligibility Criteria
You may qualify if:
- thyroid nodule diagnosed by ultrasound
- willing to undergo endoscopic thyroidectomy
You may not qualify if:
- conversion to open surgery
- unwilling to join the research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery, Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Related Publications (1)
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.
PMID: 19361288RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ming qiu, MD
Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2011
First Posted
April 19, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2011
Study Completion
June 1, 2012
Last Updated
April 19, 2011
Record last verified: 2011-04