Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

Study Overview
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Brief Summary
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Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization. One of the most annoying problem was the smog blurring endoscopic lens during surgery. The researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.

Detailed Description
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The patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group). The foot-control exhaust group used the foot-control exhaust method by the way of adjustable Pressure to intermittent exhaust, while direct exhaust group exhaust through the Trocar hole. Comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.

Official Title
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Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

Conditions
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Thyroid Cancer, Papillary Thyroid Carcinoma, Thyroidectomy, Endoscopy

Intervention / Treatment
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* Device: used of the Pressure adjustable foot-control method
* Device: direct exhaust


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with maximum tumor diameter ≤1 cm; patients without lateral neck lymph node metastases; patients without distant metastases; patients who only needed unilateral surgery following the guidelines; patients with strong cosmetic requirement. Exclusion criteria: Patients with maximum tumor diameter >1 cm; patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases; patients without cosmetic requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: This study is a prospective randomized controlled study to select a continuous case of thyroid surgery in the fujian medical university union hospital from January 2017 to June 2017.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: foot-control exhaust group<br>The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust | Device: used of the Pressure adjustable foot-control method<br>* Whether The Pressure adjustable foot-control method is used.<br>|
| Placebo Comparator: direct exhaust group<br>direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method | Device: direct exhaust<br>* direct exhaust through the trocar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flap separation time | Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space. | 1 day after surgery | 
| Glandular excision time | Glandular excision time was defined from incising cervical white line to removing Berry ligament. | 1 day after surgery | 
| Central lymph node dissection time | Central lymph node dissection time: was from separating central lymph node to the specimen removed. | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times of wiping lens | Times of wiping lens calculated from endoscopic video after operation was defined the times of wiping lens from endoscopy into the body to central lymph node removed. | 1 day after surgery | 
| Volume of intraoperative blood loss | Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss. | 1 day after surgery | 
| Volume of Postoperative drainage | Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation. | 1 day，2 day，3 day after surgery | 
| The number of identifying parathyroid glands | The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery. | 1 day after surgery | 
| Blood PTH level | measurement of PTH level in blood | preoperative, first day after operation, one week after surgery, two months after surgery. | 
| Blood calcium level | to measure the blood calcium level in the blood | before surgery, the first day after surgery, one week after surgery, two months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Thyroidectomy, Thyroid Cancer