Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy

Thyroid Tumor Clinical Trial

— ET  

Official title:

Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01338597
• Other study ID #: SMMU-2011-ET-1
• Status: Not yet recruiting
• Phase: N/A
• First received: April 11, 2011
• Last updated: April 18, 2011
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2011
• Source: Second Military Medical University
• Contact: wei zhang, MD
• Phone: -8621-81885802
• Email: zhangwei412[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• thyroid nodule diagnosed by ultrasound

• willing to undergo endoscopic thyroidectomy

Exclusion Criteria:

• conversion to open surgery

• unwilling to join the research

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Neoplasms
• Thyroid Tumor

Intervention

Procedure:
• endoscopic thyroidectomy
endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.

Locations

Country	Name	City	State
China	Department of General Surgery, Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative pain	24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)	24h post-operation	No
Secondary	number of patients with adverse effect	record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)	within 3 months after surgery	Yes