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
Sponsor:
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

April 11, 2011
April 18, 2011
April 2011
December 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01338597 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Tumor
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
  • Experimental: standard
    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.
    Intervention: Procedure: endoscopic thyroidectomy
  • Experimental: limited dissection
    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: Procedure: endoscopic thyroidectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • thyroid nodule diagnosed by ultrasound
  • willing to undergo endoscopic thyroidectomy

Exclusion Criteria:

  • conversion to open surgery
  • unwilling to join the research
Both
18 Years to 50 Years
No
Contact: wei zhang, MD -8621-81885802 zhangwei412@yahoo.com.cn
Contact: ming qiu, MD 8621-81885801 qiuming2006@yahoo.cn
China
 
NCT01338597
SMMU-2011-ET-1
No
department of general surgery, changzheng hospital
Second Military Medical University
Not Provided
Study Chair: ming qiu, MD changzheng hospital
Second Military Medical University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP