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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
History of Changes
  Purpose

The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.


Condition Intervention
Thyroid Tumor
 Procedure: endoscopic thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: 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.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • conversion to open surgery
  • unwilling to join the research
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338597

Contacts
Contact: wei zhang, MD -8621-81885802 zhangwei412@yahoo.com.cn
Contact: ming qiu, MD 8621-81885801 qiuming2006@yahoo.cn

Locations
China, Shanghai
Department of General Surgery, Changzheng Hospital Not yet recruiting
Shanghai, Shanghai, China, 200003
Contact: wei zhang, MD     8621-81885802     zhangwei412@yahoo.com.cn    
Contact: ming qiu, MD     8621-81885801     qiuming2006@yahoo.cn    
Sub-Investigator: cheng-xiang shan, MD            
Sub-Investigator: sheng liu, MD            
Sponsors and Collaborators
Second Military Medical University
Investigators
Study Chair: ming qiu, MD changzheng hospital
  More Information

Publications:

Responsible Party: department of general surgery, changzheng hospital
ClinicalTrials.gov Identifier: NCT01338597     History of Changes
Other Study ID Numbers: SMMU-2011-ET-1
Study First Received: April 11, 2011
Last Updated: April 18, 2011
Health Authority: China: Ministry of Health

Keywords provided by Second Military Medical University:
thyroidectomy
invasiveness

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on June 17, 2013