Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy

Not Applicable

• Conditions: Thyroid Tumor
• Interventions: Procedure: endoscopic thyroidectomy

• Registration Number: NCT01338597
• Lead Sponsor: Second Military Medical University

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.

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-18
• Last Update Submitted: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Posted: 2011-04-19
• Primary Completion: 2011-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
limited dissection	endoscopic thyroidectomy	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.
standard	endoscopic thyroidectomy	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.

Primary Outcome Measures

Name	Time	Method
post-operative pain	24h post-operation	24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale)

Secondary Outcome Measures

Name	Time	Method
number of patients with adverse effect	within 3 months after surgery	record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia)

Trial Locations

Locations (1)

Department of General Surgery, Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China