Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy

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

Detailed Description
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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.

Official Title
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Clinical Benefits of Reduced Subcutaneous Dissection in Endoscopic Thyroidectomy

Conditions
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Thyroid Tumor

Intervention / Treatment
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* Procedure: endoscopic thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: thyroid nodule diagnosed by ultrasound willing to undergo endoscopic thyroidectomy Exclusion Criteria: conversion to open surgery unwilling to join the research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard<br>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<br>* endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.<br>* Other names: limited flap dissection endoscopic thyroidectomy;|
| Experimental: limited dissection<br>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<br>* endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.<br>* Other names: limited flap dissection endoscopic thyroidectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | 24hs after operation, post-operative pain is evaluated by VAS(visual analoge scale) | 24h post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with adverse effect | record how many patients had adverse effects(eg. bruise, seroma, hematoma, hoarseness,hypocalciemia) | within 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, invasiveness